30/11/06 Akorn Announces Tentative Approval of Diclofenac Sodium
BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Akorn, Inc. today announced that the U.S. Food and Drug Administration has granted tentative approval for Akorn's Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Ophthalmic Solution 0.1% in 2.5 ml and 5 ml dropper bottles. Final approval is expected upon expiry of patent protection for Voltaren® Ophthalmic Solution 0.1% in October 2007.
Upon final approval, Akorn's Diclofenac Sodium Ophthalmic Solution 0.1% will be the generic equivalent of Novartis' Voltaren® Ophthalmic Solution 0.1% indicated for the treatment of post operative inflammation in ophthalmic surgeries. The brand product had annual sales of approximately $22 million in 2005, based on IMS sales data.
Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "We are excited to receive this tentative approval for Diclofenac. We intend to launch this product in October 2007. This product will be manufactured in our Somerset, New Jersey facility."
30/11/06 Actavis Acquires Abrika Pharmaceuticals in the US
- Acquisition gives Actavis a strong foothold in high value Controlled Release market
Actavis announced today that it has agreed to acquire Abrika Pharmaceuticals Inc., a US based specialty generic pharmaceuticals company engaged in the formulation and commercialization of both controlled release ("CR") and other technically difficult pharmaceutical products. Actavis has reached an agreement to acquire Abrika for an initial gross consideration of EUR85 million (US$110 million) in cash. Additional earn-out payments of up to EUR96 million (US$125 million) are payable over the next three years subject to performance.
Following the acquisition, Actavis will be one of the leading companies in the US market in development of CR products, with over 50 CR products in the pipeline, over EUR50 million expected to be invested in CR development in 2007 and 100 employees dedicated in the development of CR products. The enlarged Group has 13 pending ANDA's for CR products with the FDA.
The acquisition increases Actavis' critical mass and ability to leverage its position in the key US market.
There is limited competition in CR generics due to the complex innovation and high manufacturing standards required for successful launches. This has led to higher and more durable margins than in other segments of the US generics market.
CR versions of drugs expand the therapeutic application of products and are highly sought after by branded pharmaceutical companies because of their ability to extend product life cycles. Abrika's business model is to apply its proprietary technologies to selected high value branded pharmaceuticals and duplicate the release characteristics of the originator drugs in order to bring to market generic versions that can be substituted for these branded products.
Abrika's development expertise and infrastructure will enable Actavis to utilize its existing CR technology and accelerate growth in the niche CR market.
29/11/06 Dr. Reddy’s and Torrent Agreement For Listril And Listril Plus
November 29, 2006, Hyderabad & Ahmedabad, India: Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) and Torrent Pharmaceuticals Ltd. today announced that they have concluded an agreement for exclusive commercialization of two of Torrent’s brands in Russia, viz. Listril (Lisinopril) and Listril Plus (Lisinopril HCTZ), both of which are cardiovascular drugs used in the treatment of high blood pressure. The two brands would add to the stable of cardiovascular drugs Dr. Reddy’s is currently offering in Russia. This agreement offers the potential for immediate commercialization of these two brands as they have already been registered in Russia.
This is the second agreement of this kind that Dr. Reddy’s has made with Torrent Pharma for the territory of Russia. The first was related to the licensing for Omez D (Omeprazole 10mg + Domperidone 10mg, used to treat gastro-intestinal diseases like heartburn, dyspepsia and epigastric pain), a product that will be launched in Ukraine and Kazakhstan in the short term, followed by Russia and Belarus.
29/11/06 Teva Announces Tentative Approval of Sumatriptan Tablets
JERUSALEM--(BUSINESS WIRE)--Nov 29, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Sumatriptan Succinate Tablets, 25 mg, 50 mg and 100 mg. Final approval is expected upon expiry of patent protection for the brand product in February 2009.
Upon final approval, Teva's Sumatriptan Succinate Tablets will be the AB-rated generic equivalent of GlaxoSmithKline's Imitrex(R) Tablets, indicated for acute treatment of migraine headaches.
The brand product had annual sales of approximately $910 million for the twelve months ended September 2006, based on IMS sales data.
28/11/06 Abraxis Receives FDA Approval for Ampicillin and Sulbactam
LOS ANGELES--(BUSINESS WIRE)--Nov 28, 2006 - Abraxis BioScience, Inc., an integrated, global biopharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for the combination drug Ampicillin and Sulbactam for Injection, 15g, USP, the generic equivalent of Pfizer Inc.'s Unasyn(R). According to IMS data, annual sales in 2005 of this product exceeded $10.4 million. The company's hospital-based products division, Abraxis Pharmaceutical Products (APP), expects to commence marketing Ampicillin and Sulbactam, 15g immediately.
With this approval, APP now offers the complete line of Ampicillin and Sulbactam, which includes the 15g pharmacy bulk pack (PBP) and 1.5g and 3g single-dose vials (SDV). The product is AP rated and latex-free. The approval is the tenth product approval the company has received this year.
Ampicillin and Sulbactam is an injectable antibacterial combination consisting of the seminsynthetic antibiotic ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium. Administered intravenously or intramuscular, Ampicillin and Sulbactam is indicated for the treatment of several skin and skin structure, intra-abdominal and gynecological infections due to susceptible strains of microorganisms.
28/11/06 Does It Matter How Effective Amount is Construed?
From Patent Baristas
Earlier, the Court of Appeals for the Federal Circuit affirmed a District Court's decision that Transkaryotic Therapies Inc. (TKT) and Aventis Pharmaceuticals Inc. infringe Amgen's erythropoietin (EPO) patent estate. Amgen Inc., v. Hoechst Marion Roussel, Inc. (Now Aventis) and Transkaryotic Therapies, Inc., (05-1157). The court's decision upheld the validity of two of Amgen's EPO patents and the infringement by TKT of three patents and 12 claims, including a patent that does not expire until 2015.
Now, Amgen's petition for a panel rehearing and rehearing en banc has been denied by the Court of Appeals for the Federal Circuit.
The issue remains over the District Court's findings on the infringement and validity of two patents with claims to the production of erythropoietin, the infringement of one product patent under the doctrine of equivalents, and the validity of one product patent. The Federal Circuit found the production patents valid and infringed (U.S. Patent Nos. 5,618,698 and 5,756,349). The court reversed the District Court's determination that TKT infringed Amgen's U.S. Patent No. 5,621,080 under the doctrine of equivalents, and remanded to the District Court for further consideration of the remaining validity issue on one of the other product patents (U.S. Patent No. 5,955,422).
28/11/06 Pliva Receives Approval for Pravastatin Tablets
WOODCLIFF LAKE, N.J., November 28, 2006 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. and its subsidiary PLIVA d.d. today announced that PLIVA has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market Pravastatin Tablets 10mg, 20mg, and 40mg, the generic version of Bristol-Myers Squibb's PRAVACHOL(R) (Pravastatin Sodium) Tablets. The Company plans to launch its product immediately. PLIVA has also received tentative approval for its Pravastatin Tablets 80mg strength and plans to launch this strength following the expiration of a competitor's 180-day generic drug exclusivity period and subsequent final approval of PLIVA's application.
Pravastatin is indicated for the primary prevention of coronary events in hypercholesterolemic patients without clinically evident coronary heart disease, and secondary prevention of cardiovascular events in patients with clinically evident coronary heart disease. Pravastatin Tablets 10mg, 20mg and 40mg compete in a market that had total U.S. sales of approximately $1.2 billion, based on IMS data for the 12-month period ending September 2006.
22/11/06 Teva Announces Approval of Ondansetron Injection USP
JERUSALEM, Israel--(BUSINESS WIRE)--Nov 22, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Applications (ANDAs) for Ondansetron Injection USP, 2 mg/mL, packaged in 4 mg/2 mL single-dose vials, 2 mg/mL, packaged in 40 mg/20 mL multiple-dose vials and 0.64 mg/mL packaged in 32 mg/50 mL bags.
Shipment of these products will begin immediately following a 2005 patent litigation settlement with GlaxoSmithKline.
Teva's Ondansetron Injection products are the AP-rated generic equivalent of GlaxoSmithKline's antiemetic Zofran(R) Injection.
The product, in the three configurations, had annual sales of approximately $695 million for the twelve months ended September 2006, based on IMS sales data.
22/11/06 AstraZeneca & Par Agree on Authorized Generic TOPROL-XL
AstraZeneca today announced it has entered into a supply and distribution agreement with Par Pharmaceutical to distribute an authorized generic version of metoprolol succinate in the United States. Currently, the authorized generic product will be distributed in the 25 mg dosage strength. The signing of this agreement does not affect the availability of AstraZeneca’s branded version of metoprolol succinate, TOPROL-XL. AstraZeneca will continue to manufacture and make TOPROL-XL available in the United States.
A 25 mg version of metoprolol succinate was launched in the United States yesterday by Eon Labs, part of Sandoz. The 25 mg dose accounts for an estimated 20 per cent of AstraZeneca’s TOPROL-XL sales in the US.
The Full Year EPS guidance of $3.85 to $3.95 announced with the Third Quarter 2006 results excluded any one-off costs and inventory adjustments associated with the possible launch of generic metoprolol succinate. These one-off costs and inventory adjustments are now calculated to be approximately $150m or 8 cents per share and will be charged in the fourth quarter. After accounting for this, the company now expects the full year EPS guidance to be at the lower end of the $3.85 to $3.95 range previously announced.
On January 17, 2006, a US District Court, in litigation involving KV Pharmaceutical Company, Andrx Pharmaceuticals LLC, Andrx Corporation, and Eon Labs Manufacturing, Inc., held the patents covering TOPROL-XL (metoprolol succinate) extended release tablets to be invalid and unenforceable. AstraZeneca strongly disagrees with the court’s decision, and filed a Notice of Appeal in February to the US Court of Appeals for the Federal Circuit. A decision regarding this appeal is pending. The patent protecting TOPROL-XL expires September 18, 2007.
22/11/06 IMPAX Announces Earlier Riluzole Decision Back to Lower Court
HAYWARD, Calif.--(BUSINESS WIRE)--Nov. 22, 2006--IMPAX Laboratories, Inc. today announced that the United States Court of Appeals for the Federal Circuit ruled that the district court had erred in deciding, after trial, that the patent relating to the use of riluzole in treating ALS (Pat. No. 5,527,814) was valid and has vacated that decision and remanded it back to the district court for further proceedings related to the validity issue of anticipation. On December 12, 2002, in an earlier decision, the United States District Court for the District of Delaware granted a preliminary injunction motion brought by Aventis on October 15, 2002, which delayed IMPAX's entry into the market. IMPAX's ANDA for its generic version of Rilutek(R) (riluzole) 50mg tablets was approved on January 29, 2003. IMPAX expects to request that the injunction preventing the Company from launching its generic version of Rilutek(R) be lifted upon return of the case to the lower court.
Rilutek(R), marketed by Aventis for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, had U.S. sales of approximately $37 million for the 12 months ended August 31, 2006, according to Wolters Kluwer Health.
"We are pleased that the Federal Circuit decided to remand this case back to the lower court as we believe that it is important to make an affordable alternative available to patients suffering from ALS," commented Larry Hsu, Ph.D., President and CEO of IMPAX Laboratories. "We continue to remain optimistic about the eventual outcome of this patent validity challenge."
21/11/06 Actavis Expands Presence in Russia
Purchase of majority stake in Russian manufacturing facility strengthens position in fast growing market.
Actavis announced today that it has acquired a 51% controlling interest in ZiO Zdorovje, a leading Russian pharmaceutical manufacturer.
The total commitment by Actavis is EUR47 million (US$60 million), of which EUR23 million (US$30 million) will be made available for investment for ZiO Zdorovje's world class manufacturing site to introduce new products and create a platform for increased production and capacity. This investment combined with the 49% stake that the current owners of ZiO Zdorovje will retain in the business going forward, underlines how committed both parties are to working closely together going forward.
Russia is one of the fastest growing markets in the generic industry with growth forecast at an annual rate of 15-17% during next 5 years. Russia is already Actavis' seventh largest market, accounting for approximately 4% of the Groups annual sales. Actavis is confident that this transaction will significantly enhance its prospects in the Russian market and establish a platform for sustainable growth going forward.
The transaction will enable Actavis to transfer production of certain products to Russia and provide the Group with a local manufacturing presence that will help to facilitate participation in state hospital tenders.
21/11/06 Teva Agree With Pfizer - Idarubicin, Azithromycin & Epirubicin
Jerusalem, Israel, November 21, 2006 - Teva Pharmaceutical Industries Ltd. announced today that it has reached a comprehensive agreement with Pfizer Inc regarding idarubicin, azithromycin, and epirubicin and the sale of those generic products. The agreement resolves and dismisses all outstanding patent litigation filed by Pharmacia, a subsidiary of Pfizer against Sicor, a subsidiary of Teva, over Sicor's sales of generic idarubicin, an anti-cancer drug and all patent litigation brought by Pfizer over Teva's sale of generic azithromycin, an antibiotic. Furthermore, the parties have granted each other full releases and Teva will continue to market its generic versions of idarubicin and azithromycin. Teva has agreed to make a payment of up to $70 million to Pfizer, which includes an option in 2007 for Teva to sell its own generic version of epirubicin prior to the August 2007 patent expiry. Additional details were not disclosed.
20/11/06 Hospira, STADA and BIOCEUTICALS Erythropoietin Agreements
-- Collaboration Expected to Result in One of the First Introductions of a Biosimilar Erythropoietin in Europe --
LAKE FOREST, Ill., Nov. 20, 2006 -- Hospira, a leading global hospital products company, STADA Arzneimittel AG, and BIOCEUTICALS Arzneimittel AG, a STADA-initiated company focused on biosimilar products, today announced development, manufacturing and distribution agreements for a biosimilar version of erythropoietin (EPO). Naturally occurring erythropoietin is a protein hormone produced in the body by the kidney. Therapeutic erythropoietin is used primarily in the treatment of anemia in dialysis and in certain oncology applications.
"Developing and providing access to biosimilars is a natural extension of Hospira's leadership position in generic injectable pharmaceuticals and an important part of our strategy of investing for growth," said Christopher B. Begley, chief executive officer, Hospira. "The collaboration will help expand the availability of a more cost-effective alternative to EPO medications currently on the market, furthering our ability to take additional costs out of the global healthcare system."
Through the agreements, Hospira obtains exclusive distribution rights for BIOCEUTICALS' erythropoietin in the European Union (EU) and several other European countries, with the exception of Germany, where it holds semi-exclusive rights. Hospira will retain exclusive distribution rights in the United States and Canada, where it will also be solely responsible for the development and manufacture of the product. Additionally, Hospira holds a first right of refusal for the distribution rights in all other countries. BIOCEUTICALS will receive an approximate US$21 million upfront payment, up to an additional US$34 million in payments over the next several years contingent upon meeting specified objectives, and incremental royalty payments on commercial sales. Further details were not disclosed.
17/11/06 FDA Tentative Approval of Triple Drug Fixed Dose Combination
ROCKVILLE, Md., Nov. 17, 2006-On November 17, 2006, the Food and Drug Administration (FDA) granted tentative approval for a new fixed drug combination of stavudine/lamivudine/nevirapine tablets manufactured by Cipla Limited, of Mumbai, India. This product was reviewed under expedited procedures for the President's Emergency Plan for AIDS Relief (PEPFAR) program.
Stavudine, lamivudine, and nevirapine are anti-viral drugs for the treatment of HIV-1 infection. This product represents a new combination which can significantly decrease pill burden and could result in improved compliance for HIV infected individuals.
FDA's tentative approval of this product means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the product has been shown to meet all of FDA's safety, efficacy, and manufacturing quality standards required for marketing in the U.S., and thus qualifies for consideration for purchase under PEPFAR.
17/11/06 Fougera Receives Approval for Generic Sulfacetamide Sodium
MELVILLE, N.Y., Nov. 17 /PRNewswire/ -- Specialty pharmaceutical manufacturer Fougera, a division of ALTANA Inc, announced today that it has received FDA approval to bring to market the first generic Sulfacetamide Sodium Topical Suspension USP 10% (Rx). The generic formulation compares to KLARON(R) by Dermik, whose patent has expired. The market for the brand name product was approximately $25 million in 2005.
Sulfacetamide Sodium Topical Suspension USP 10% (Rx) is indicated for the topical treatment of acne. The Fougera product (NDC #0168-0382-04) is available in 118 mL (4 fl oz) bottles and began shipping today.
David Klaum, Senior Vice President, Commercial Business Operations, said, "Fougera will be first to market with generic Sulfacetamide Sodium Topical Suspension USP 10% (Rx), continuing our track record of receiving more topical generic FDA approvals than any other company during the past six years. The introduction of this product is another example of Fougera's continuing commitment to offer healthcare providers an ever expanding product portfolio to meet their patients' needs."
17/11/06 Mayne Pharma Loses Patent Litigation to AstraZeneca
From Patent Circle
Australian-based Mayne Pharma has lost a patent infringement lawsuit in the U.S. Court of Appeals for the Federal Circuit for an anesthetic drug Propofol, which upholds a U.S. District Court for the Southern District of New York decision finding that Mayne’s injectable formulation of propofol infringed patents held by AstraZeneca.
Earlier on June 28, 2002 ESI filed an abbreviated new drug application (ANDA) along with Para IV certification, seeking marketing approval for generic propofol formulation. In respone, AstraZeneca filed a patent infringement lawsuit against ESI on October 04, 2002 alleging that ESI proposed generic propofol infringes AstraZeneca’s U.S. Patent Nos. 5,714,520 (the ‘520 patent), 5,731,355 (the ‘355 patent) and 5,731,356 (the ‘356 patent). Thereafter, Mayne, an indirect assignee of ESI, sent AstraZeneca a notice letter dated July 15, 2003 informing its intent to commercially manufacture, use or sell its generic propofol formulation in 50ml and 100ml vials. AstraZeneca reacted by filing a second lawsuit, and both actions were consolidated.
On December 28, 2004 the District Court issued a Markman ruling, construing three contested terms including “edetate” which timely appealed by Mayne. After eleven day of bench trial, the District Court entered judgment in the favor of AstraZeneca concluding that the filing of Mayne’s ANDA infringed asserted claims of the patents in suit.
14/11/06 Warner Chilcott Announces Settlement of Yaz(R) Litigation
HAMILTON, Bermuda, Nov 14, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Warner Chilcott Limited (Nasdaq: WCRX) announced today that Schering will license to Warner Chilcott its proprietary selective glucocorticoid receptor agonist (SEGRA) compound for the oral or topical treatment of inflammatory skin diseases. Warner Chilcott will pay a royalty to Schering on sales of any product containing the SEGRA compound under the license.
In addition, Warner Chilcott and Schering have reached a settlement in the patent case filed by Warner Chilcott Company, Inc. against Berlex Inc. and Schering AG, in the United States District Court for the District of New Jersey, in connection with Warner Chilcott's U.S. Patent No. 5,552,394 and relating to the marketing and sale of Yaz(R). Schering will make certain payments to Warner Chilcott in connection with the settlement.
The terms of the agreements are confidential and subject to clearance by the Federal Trade Commission under the Hart Scott Rodino Antitrust Improvements Act of 1976, as amended.
14/11/06 FDA Improperly Delists Merck's Zocor Orange Book Patents
From Orange Book Blog
The Court of Appeals for the D.C. Circuit today affirmed a district court decision finding that the FDA wrongly delisted two Merck patents on Zocor (simvastatin), which in turn unlawfully denied Teva and Ranbaxy from 180 days of marketing exclusivity on generic simvastatin. FDA appealed the district court decision but did not request a stay. FDA then granted final approval of Teva and Ranbaxy's ANDAs in June, after which the two companies launched their generic simvastatin products.
In today's D.C. Circuit opinion, written by Judge Ginsburg for a unanimous panel, the court upheld the district court's finding that FDA's interpretation of the statue was contrary to the clear intent of Congress. FDA's policy was to allow delisting when a generic drug maker had filed an ANDA containing a paragraph IV certification and the NDA holder had not filed a lawsuit to contest the certification, as occured in the Zocor case.
The appeals court framed the question at issue as "whether the FDA may delist a patent upon the request of the NDA holder after a generic manufaturer has filed an ANDA containing a paragraph IV certification so that the effect of delisting is to deprive the applicant of a period of marketing exclusivity." In striking down FDA's policy, the court reasoned:
Not only does the statute not require litigation to preserve a generic applicant's eligibility for exclusivity . . . such a requirement is inconsistent with the structure of the statute because, if the patent is delisted before a pending ANDA is approved, then the generic manufacturer may not initiate a period of marketing exclusivity.
By thus reducing the certainty of receiving a period of marketing exclusivity, the FDA's delisting policy diminishes the incentive for a manufacturer of generic drugs to challenge a patent listed in the Orange Book in the hope of bringing to market a generic competitor for an approved drug without waiting for the patent to expire. The FDA may not, however, change the incentive structure adopted by the Congress.
This case appears to require FDA to set a new policy, whereby it should refuse to delist a patent if a generic manufacturer has filed an ANDA containing a paragraph IV certification with respect to the patent.
14/11/06 Court of Appeals Affirms Teva's Generic Zocor Exclusivity
JERUSALEM, Israel--(BUSINESS WIRE)--Nov 14, 2006 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Court of Appeals for the Federal Circuit affirmed a May 1, 2006 decision by the District Court awarding the Company 180-day exclusivity for its generic version of Merck's Zocor(R) (Simvastatin) Tablets.
On June 23, 2006, Teva received final approval from the FDA to market its Simvastatin Tablets, 5 mg, 10 mg, 20 mg, and 40 mg and immediately commenced shipment of these products. As the first company to file an ANDA containing a paragraph IV certification for these strengths, Teva was eligible to receive 180-day Hatch-Waxman statutory exclusivity to market these products. Teva's exclusivity will run through Dec. 20, 2006.
14/11/06 Omnicare Enters into Voluntary Settlement Agreement
COVINGTON, Ky.--(BUSINESS WIRE)--Nov 14, 2006 - Omnicare, Inc., the nation's leading provider of pharmaceutical care for the elderly, today said that it has reached a voluntary civil settlement with the federal government and 42 states related to a previously disclosed review of three generic pharmaceuticals provided by the Company in connection with the substitution of capsules for tablets (Ranitidine), tablets for capsules (Fluoxetine) and two 7.5 mg tablets for one 15 mg tablet (Buspirone). The Company cooperated fully with the review of these matters and said that it is pleased that the matter has been resolved. The Company believes that it has now resolved these issues with all the states in which it does business. The Company also noted that patient safety was never an issue.
The Settlement Agreement does not include any finding of wrongdoing or any admission of liability by Omnicare. The Company agreed to settle the matter in order to avoid expensive and time-consuming litigation and to focus on its mission of providing high-quality pharmaceutical care for the frail elderly.
13/11/06 Apotex Sues FDA Over Decision on Generic Zofran
From Orange Book Blog
Apotex filed a complaint and motion for preliminary injunction against the FDA in the U.S. District Court for the District of Columbia last week, alleging that the FDA unlawfully refused to acknowledge that the dismissal of its patent infringement suit against GlaxoSmithKline over generic Zofran was a "court decision" triggering the first ANDA filer's 180 day period of exclusivity. The dismissal order was entered May 25, 2005, and therefore Apotex claims that the 180 day exclusivity period expired in November, 2005. Apotex would like to launch its generic Zofran next month, when the last of GSK's patents expire. Unless the FDA changes its position, however, Apotex will have to wait until at least 180 days later.
Apotex had previously challenged the FDA's interpretation of a "court decision" sufficient to trigger a 180 day exclusivity period, in a declaratory judgment action involving generic Pravachol. In that case, FDA decided that the dismissal of a patent suit was not such a court decision; instead, a court must issue a holding on the merits of the suit. FDA explained in a November 3rd letter to counsel for Apotex that its "holding-on-the-merits" standard "is equally applicable to affirmative patent suits," such as the Zofran case. Apotex filed its lawsuit against the FDA shortly after receiving the letter.
The impact of this case will be relatively limited because the Medicare Modernization Act of 2003 got rid of the "court decision" trigger entirely. For ANDAs filed after December 8, 2003, if no other ANDAs containing a paragraph IV certification for the listed drug were filed prior to December 8, 2003, a court decision no longer triggers the 180-day exclusivity period. Instead, the exclusivity period does not begin until the first commercial marketing of the generic drug.
13/11/06 Spectrum Announces Agreement With GSK Over Imitrex
Spectrum Filed ANDA With Paragraph IV Certification for Sumatriptan Injection in October 2004 and Received Tentative Approval From the FDA in October 2006
IRVINE, Calif., November 13, 2006 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. today announced that it has settled a patent litigation with GlaxoSmithKline relating to sumatriptan injection, the generic version of GlaxoSmithKline's Imitrex Injection.
The confidential terms of the settlement, which remain subject to government review, provide that Spectrum may exclusively distribute authorized generic versions of certain sumatriptan injection products in the United States with an expected launch during GSK's sumatriptan pediatric exclusivity period which begins on August 6, 2008, but with the launch occurring not later than November 6, 2008. Spectrum will launch sumatriptan injection through its partner for the sale and distribution of the drug, Par Pharmaceuticals Companies, Inc. .
GlaxoSmithKline's Imitrex Injection (sumatriptan succinate injection) for the acute treatment of migraine attacks and the acute treatment of cluster headache episodes has annual U.S. sales of approximately $220 million, according to IMS Health.
"This settlement with GlaxoSmithKline for sumatriptan injection represents another milestone achieved by Spectrum this year, as we now have clarity regarding our exclusive launch of the important products covered under this agreement," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "Spectrum will receive the majority of the profits from the sale of sumatriptan injection, and we expect to use those profits to fund the further development of our proprietary drug pipeline."
In February 2006, Spectrum entered into an agreement with Par Pharmaceutical to develop and market generic drugs for the company, including sumatriptan injection. In 2004, Spectrum filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration seeking marketing clearance for sumatriptan injection, which was approved by the FDA in October 2006.
13/11/06 Taro Receives Marketing Authorization in UK for Etopan XL
HAWTHORNE, N.Y.--(BUSINESS WIRE)--Nov 13, 2006 - Taro Pharmaceutical Industries Ltd. reported today that Taro Pharmaceuticals (UK) Limited ("Taro UK"), its affiliate in the United Kingdom, has been granted a marketing authorization for Etopan XL Tablets 600 mg, Etodolac ("Etopan XL") by the Medicines and Healthcare Products Regulatory Agency, the UK equivalent of the U.S. Food and Drug Administration.
Etopan XL, a prescription product, is the first approved UK generic alternative to Lodine(TM) SR Tablets 600 mg, which is marketed in the UK by Shire Pharmaceuticals. Etopan XL is a non-steroidal anti-inflammatory drug taken for acute or long-term use in rheumatoid arthritis and osteoarthritis. According to industry sources, Lodine(TM) SR Tablets have annual sales of approximately US$18 million in the UK.
"The introduction of Etopan XL represents a significant addition to our product portfolio in the UK," said Samuel Rubinstein, Senior Vice President and General Manager of Taro and the head of Taro's European operations.
Tarodent Marketing Authorization in the UK
Taro UK has also been granted a marketing authorization by the Medicines and Healthcare Products Regulatory Agency for Tarodent 0.2% Mouthwash, 0.2% w/v chlorhexidine digluconate ("Tarodent Mouthwash"). Tarodent Mouthwash, an over-the-counter product, is a generic alternative to Corsodyl Mouthwash, which is marketed in the UK by GlaxoSmithKline Consumer Healthcare. Tarodent Mouthwash is used for the treatment and prevention of gingivitis, maintenance of oral hygiene and treatment of oral thrush and mouth ulcers.
10/11/06 Teva Introduces Oxybutynin Chloride Extended-Release Tabs
NORTH WALES, Pa., Nov. 10, 2006 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Oxybutynin Chloride Extended-Release Tablets. This product is AB rated and bioequivalent to Ditropan XL®* Extended-Release Tablets. Oxybutynin Chloride Extended-Release Tablets are available in 15 mg strength, in a bottle size of 100 tablets.
“We are pleased to announce our launch of Oxybutynin Chloride Extended-Release Tablets,” states John W. Denman, Vice President, Sales & Marketing. “This new product continues our long tradition of providing customers with generic drugs of the highest quality, yet at affordable pricing.”
10/11/06 Impax Receives Final FDA Approval for Generic Ditropan XL
HAYWARD, Calif.--(BUSINESS WIRE)--Nov 10, 2006 - IMPAX Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Ditropan(R) XL, Extended-release Tablets, 15 mg (Oxybutynin Chloride Extended-release Tablets 15 mg). The FDA also awarded the Company first-to-file status and 180-day market exclusivity for this product. Alza Pharmaceuticals markets Ditropan XL for the treatment of urge urinary incontinence. U.S. sales of Ditropan XL 15 mg were approximately $58 million in the 12 months ended August 31, 2006, according to Wolters Kluwer Health.
The Company's version of generic Ditropan XL 15 mg is one of 12 products covered under its strategic alliance entered into in June 2001 with a subsidiary of Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA). Teva plans to begin marketing the product immediately.
"We are very pleased to now have eight FDA approvals this year and look forward to working with our partner on the launch of our generic version of 15 mg Ditropan XL," said Larry Hsu, President and Chief Executive Officer of IMPAX Laboratories. "We had expected this approval following the September 2006 appeals court ruling in our favor in a patent infringement suit brought against us by Alza," he added.
The Company noted that it continues to have tentative approval for its 5 mg and 10 mg versions of generic Ditropan XL. Conversion of the 5 mg and 10 mg strengths from tentative approval to final approval is contingent upon the expiration of any generic marketing exclusivity by other applicants. Final approval also is dependent upon FDA's evaluation of any new information subsequent to the tentative approval. Wolters Kluwer Health estimates that U.S. sales of all dosage forms of Ditropan XL Extended-release Tablets were approximately $338 million in the 12 months ended August 31, 2006.
10/11/06 Mylan Receives Final FDA Approval for Oxybutynin Chloride
PITTSBURGH, November 10, 2006 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Applications (ANDAs) for Oxybutynin Chloride Extended-release Tablets, 5 mg and 10 mg, and Mylan has launched these products immediately. Oxybutynin Chloride ER Tablets are the generic version of Alza Corporation's Ditropan XL(R) Extended-release Tablets. Ditropan XL(R) had U.S. sales of approximately $380 million during the 12-month period ended June 30, 2006, with more than 82% of the volume in the 5 mg and 10 mg strengths, according to IMS.
Robert J. Coury, Mylan's Vice Chairman and Chief Executive Officer commented: "This is the latest milestone achievement in Mylan's long history of successfully developing difficult to formulate and difficult to manufacture generic products. Mylan has once again differentiated itself in the industry through the successful development of this product, and based on the limited number of competitors that have filed oxybutynin applications, we expect that it will be a valuable component of our product portfolio for the 180 days of market exclusivity and beyond."
Mylan is the first generic drug company to file ANDAs with the FDA for 5 mg and 10 mg Ditropan XL(R), and as such, the company has 180 days of market exclusivity for those strengths. Mylan has entered into two agreements with Ortho-McNeil Pharmaceuticals and Alza that ensures Mylan's ability to launch the 15 mg strength at market formation.
10/11/06 Shire Sues Andrx Pharmaceuticals, L.L.C.
BASINGSTOKE, England and PHILADELPHIA, Pennsylvania, November 10, 2006 /PRNewswire-FirstCall/ -- Shire plc announces that its subsidiary Shire Laboratories Inc. has filed lawsuits in the US District Court for the District of New Jersey and the Southern District of Florida against Andrx Pharmaceuticals, L.L.C. and Andrx Corporation (collectively "Andrx") for infringement of Shire Laboratories' US Patent Nos. 6,322,819 ('the '819 Patent') and 6,605,300 ('the '300 Patent'). Watson Pharmaceuticals , Inc., the recent acquirer of Andrx, is also being named in the lawsuits.
The lawsuits result from an Abbreviated New Drug Application filed by Andrx for generic versions of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg ADDERALL XR(R), pursuant to which Andrx provided notice that it would seek to market its generic products before the expiration of the '819 and '300 Patents in 2018. The lawsuits allege that all of Andrx's generic strengths infringe the patents in suit. Pursuant to Hatch-Waxman legislation, there will be a 30-month stay with respect to Andrx's proposed generic products.
ADDERALL XR is a Shire Attention Deficit Hyperactivity Disorder medicine.
09/11/06 Federal Circuit Invalidates Abbott's Sevoflurane Patent
From Orange Book Blog
The Federal Circuit today reversed a district court decision that upheld the validity of Abbott's U.S. Patent No. 5,990,176, finding instead that Abbott's patent is inherently anticipated by U.S. Patent No. 5,684,211. The '176 patent covers compositions of and processes for making sevoflurane, an inhalation anesthetic that Abbott sells under the brand names Ultane and Sevorane. In 2001 Baxter filed an ANDA to market generic sevoflurane.
The '176 patent claims compositions comprising sevoflurane and a Lewis acid inhibitor (such as water) in an amount effective to prevent degradation of sevoflurane. The '211 patent discloses a water-saturated sevoflurane composition, though the inventors did not recognize at the time that the water in the composition prevented degradation of sevoflurane. At trial, the U.S. District Court for the Northern District of Illinois relied on Bristol-Myers Squibb v. Ben Venue in concluding that the '211 patent did not inherently anticipate the '176 patent because the purpose of the '211 patent was not to produce sevoflurane in its final usable form, in distinction to the purpose of the patent-in-suit.
The Federal Circuit's decision, written by Judge Garjarsa for a unanimous panel, noted initially that BMS v. Ben Venue applies only to process claims, and therefore is inapplicable to the composition claims of the '176 patent. With regard to the process claims of the '176 patent, the Federal Circuit disagreed that the processes described in the '176 and '211 patents are directed to the same purpose. The court stated: "All that is contributed by the method claims of the '176 patent is the recognition of a new property of the prior art process."
Judge Gajarsa's opinion reaffirms the general principle that "a reference may anticipate even when the relevant properties of the thing disclosed were not appreciated at the time." In support of this principle, the Federal Circuit cited its own 1985 opinion in Titanium Metals and an 1892 Supreme Court decision, Ansonia Brass & Copper Co.
09/11/06 Barr Gets Tentative Approval for Generic Zyprexa Zydis Tablets
WOODCLIFF LAKE, N.J., November 09, 2006 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Eli Lilly and Company's ZYPREXA(R) Zydis(R) (Olanzapine) Orally Disintegrating Tablets, 5mg, 10mg, 15mg and 20mg. The Company anticipates receiving final approval following the expiration of the 30-month stay in April 2007.
The patent listed in the Orange Book for ZYPREXA Zydis expires on April 23, 2011. Barr's Abbreviated New Drug Application (ANDA) alleges that the Orange Book listed patent is invalid, unenforceable and/or would not be infringed by Barr's product.
Barr filed its ANDA containing a paragraph IV certification for a generic ZYPREXA Zydis product with the FDA in August 2004, and received notification of the application's acceptance for filing in September 2004. Following receipt of the notice from the FDA, Barr notified Lilly Industries Limited, the patent owner, and Eli Lilly & Company, the New Drug Application (NDA) holder. On December 1, 2004, Lilly Industries Limited and Eli Lilly & Company filed suit in U.S. District Court, Southern District of Indiana to prevent Barr from proceeding with the commercialization of its product, formally initiating the patent challenge process under the Hatch-Waxman Act.
ZYPREXA (olanzapine) is indicated for the treatment of schizophrenia and for the short-term treatment of acute manic episodes associated with Bipolar I disorder. The product had annual sales of approximately $246 million for the twelve months ended September 2006, based on IMS sales data.
A tentative approval reflects FDA's preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed non-approval periods. A tentative approval does not allow the applicant to market the generic drug product.
09/11/06 Update on US Lexapro Court Case
COPENHAGEN, Denmark, Nov. 9, 2006--In 2003, Forest Laboratories, Inc. and H. Lundbeck A/S filed suit against Ivax Pharmaceuticals, Inc, now Teva Pharmaceuticals (Teva), for patent infringement related to Lexapro patent. A trial was held regarding the patent litigation with Teva in March 2006 and on July 13, 2006, the U.S. District Court for the District of Delaware determined that the patent covering Lexapro is valid and enforceable. Lexapro’s patent is set to expire in March 2012.
Following the issuance of the final judgement order Teva has filed an appeal of the court’s ruling.
08/11/06 Taro Receives ANDA Approval For Meloxicam Tablets
Company Also Receives Tentative ANDA Approval for Cetirizine Syrup, Generic Equivalent to Zyrtec
HAWTHORNE, N.Y., Nov. 8, 2006 (PRIMEZONE) -- Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application (ANDA") for Meloxicam Tablets, 7.5 mg and 15 mg ("meloxicam tablets").
Taro's meloxicam tablets are used for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis. This new Taro prescription product is bioequivalent to Boehringer Ingelheim's Mobic(r) Tablets. According to industry sources, branded and generic meloxicam tablet products had U.S. sales of approximately $105 million in the third quarter of 2006.
Tentative Approval of Cetirizine Syrup in the U.S.
Taro also reported today that it has received tentative approval from the FDA for its Abbreviated New Drug Application ("ANDA") for Cetirizine Hydrochloride Syrup, 1 mg/mL ("cetirizine syrup").
The FDA has determined that Taro's cetirizine syrup is safe and effective for use when compared with the reference listed drug product, Zyrtec(r) Syrup of Pfizer, Inc. Zyrtec(r) Syrup is a prescription product used for treating allergic rhinitis and chronic urticaria (hives). The tentative ANDA approval for Taro's cetirizine syrup is an FDA determination that Taro's ANDA submission for this product currently satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities and restrictions, or any new information that may come to the FDA's attention. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission. According to industry sources, annual U.S. sales of Zyrtec(r) Syrup are approximately $153 million. It is expected that, upon the December 2007 expiration of the pediatric exclusivity covering Zyrtec(r) Syrup, as allowed under applicable law, there will be additional generic competition for Zyrtec(r).
08/11/06 Mylan Announces Final FDA Approval for Doxycycline Tablets
PITTSBURGH, November 08, 2006 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Tablets, 50mg, 75mg and 100mg.
Doxycycline Tablets are a generic version of Doak Dermatologics' Adoxa(R) Tablets (manufactured by Par Pharmaceuticals). Doxycycline Tablets had U.S. sales of approximately $56 million for the three strengths approved for the 12-month period ended June 30, 2006, according to IMS Health.
This product will be shipped immediately.
08/11/06 Orbus Signs Agreement for the Canadian Market
TORONTO, ONTARIO--(CCNMatthews - Nov. 8, 2006) - Orbus Pharma Inc. today announced that it has entered into an exclusive license, supply and distribution agreement with Gennium Pharma Inc. ("Gennium") of Mississauga, Ontario, to supply a generic cephalosporin to the Canadian market.
Orbus' product is a fast release formulation which is the subject of a patent application pending in the Canadian Intellectual Property Office, as well as in the European Patent Office. The total Canadian market sales in 2005, is approximately $10.5million.
Under the agreement, Orbus will manufacture the product at its Cambridge, Ontario plant and Gennium will file an Abbreviated New Drug Submission (ANDS) with Health Canada and will market and distribute the generic drug product under the Gennium name in the Canadian market. Financial terms of the Agreement were not disclosed.
"We are pleased with this new collaboration" said Jeff Renwick, President and CEO of Orbus. "We believe this ten year supply agreement is the start of a long-term relationship with an important partner."
06/11/06 FDA Tentative Approval of Generic Abacavir Sulfate
ROCKVILLE, Md., Nov. 6, 2006--The Food and Drug Administration, on November 6, 2006, granted tentative approval for a generic formulation of abacavir sulfate tablets, 300 mg, manufactured by Cipla Limited of Mumbai, India. The application was reviewed under the expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR).
FDA's tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., and can thus be considered for purchase under PEPFAR.
As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to these applications to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.
This tentatively approved product, a generic version of Ziagen tablets manufactured by GlaxoSmithKline, is a nucleoside reverse transcriptase inhibitor (NRTI) for use in combination with other antiretroviral agents in the treatment of HIV infection.
06/11/06 Actavis Launches Glipizide ER Tablets in the U.S.
Glipizide ER tablets are used to treat type 2 diabetes in patients, particularly in people whose diabetes cannot be controlled through diet alone. Glipizide ER tablets are the authorized generic product of Pfizer's Glucotrol XL® tablets. The product is acquired by Actavis from Andrx Pharma as part of a Federal Trade Commission ("FTC") divestiture requirement. Actavis' product is AB rated to Glucotrol XL® tablets.
Glipizide ER tablets are available in 2.5mg, 5mg, and 10mg strengths. Total annual sales of Glipizide ER tablets from all suppliers in the U.S. were approximately US$195 million for the twelve months ending June 2006 according to IMS Health.
03/11/06 Impax Receives FDA Approval for Generic Urecholine Tablets
HAYWARD, Calif.--(BUSINESS WIRE)--Nov 3, 2006 - IMPAX Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Abbreviated New Drug Applications (ANDA) for generic versions of Urecholine(R) Tablets (Bethanechol Chloride Tablets USP) 5 mg, 10 mg, 25 mg, and 50 mg. Odyssey Pharmaceuticals, Inc. markets Urecholine for the treatment of acute post-operative and post partum non-obstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention. Sales of both the branded and generic versions of Urecholine Tablets were approximately $33 million in the 12 months ended August 31, 2006, according to Wolters Kluwer Health.
"These ANDA approvals, our fourth through seventh this year, provide further validation of our strategy to develop niche generic pharmaceuticals," said Larry Hsu, Ph.D., IMPAX's President and Chief Executive Officer. "Our Global Pharmaceuticals division will begin marketing our generic Urecholine soon."
03/11/06 Merck Wins in Fosamax Hearing in Australia
Merck Sharp & Dohme has won an injunction against GenRx that could hold off further competition and a price cut for its big-selling osteoporosis drug, Fosamax well into next year.
For full details on the case please click on the link below.
02/11/06 Ranbaxy Tenntative Approval For Cetirizine HCl Syrup
PRINCETON, N.J., November 02, 2006 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Cetirizine Hydrochloride Syrup, 5 mg/5 ml. Total annual market sales for Cetirizine Hydrochloride Syrup were $146.3 million (IMS - MAT: June 2006).
Cetirizine Hydrochloride Syrup is indicated for the relief of symptoms associated with seasonal allergic rhinitis due to allergens such as ragweed, grass and tree pollens in adults and children 2 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, nasal pruritus, ocular pruritus, tearing, and redness of the eyes. Cetirizine Hydrochloride Syrup is also indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in adults and children 6 months of age and older. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Cetirizine Hydrochloride Syrup is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.
"We are pleased to receive this tentative approval for Cetirizine Hydrochloride Syrup. This product represents a future opportunity for Ranbaxy and will be produced in our dedicated liquid manufacturing facility located in Gloversville, New York and will be launched following final approval from the FDA. This will further expand our product portfolio of affordable generic alternatives," according to Jim Meehan, Vice President of Sales and Marketing for RPI.
02/11/06 Teva Withdraws Challenge from EPO in OxyContin® Case
CAMBRIDGE, England, Nov. 2, 2006 - Mundipharma International Ltd announces a strengthening of its position with respect to European patents on its leading product, OxyContin® (oxycodone HCl controlled-release) tablets, following an agreement between Purdue Pharma L.P. and its associated companies and Teva Pharmaceuticals that has led to the withdrawal by Teva Pharmaceuticals Europe B.V. of its challenge to OxyContin® patents in the European Patent Office and cancellation of the patent infringement case that was pending in the Netherlands District Court of the Hague.
Teva's withdrawal of its European challenge and cancellation of its infringement case involving OxyContin® come after Teva recognised the validity of the OxyContin® patents pursuant to an agreement with the Purdue companies executed on August 29, 2006. Under the terms of that agreement, Teva also admits that the OxyContin® patents are infringed by Teva's extended-release oxycodone products. In the United States, Teva will discontinue sales of its generic version of OxyContin® subject to certain contingencies contained in its agreement with Purdue that permit Teva to remain on the market at least through March 31, 2007.
The Teva agreement follows a decision by the United States Court of Appeals for the Federal Circuit that vacated a previous trial court finding of unenforceability: "The patents being asserted in favour of OxyContin® have been properly examined and rightly granted. We will vigorously defend the rights they convey against anyone who attempts to infringe on those rights" said Ĺke Wikström, Regional Director, Europe, Mundipharma International Ltd.
Separately, Endo Pharmaceuticals Inc. has agreed that its extended-release oxycodone products infringe certain of Purdue's, and its associated companies', OxyContin® patents in the U.S., Europe and Canada and that it will not dispute the validity of any of Purdue's, or its associated companies', patents anywhere in the world. Consent judgments reflecting some of the terms of the Teva and Endo settlements have been signed and entered by a federal judge of the United States District Court for the Southern District of New York.
02/11/06 Akorn & Natco Add Two Injectable Drugs To Agreement
BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Nov 2, 2006 - Akorn, Inc. today announced that it has added two injectable drug products to its API Supply and Margin Sharing Agreement with Natco Pharma Limited (NSE: NATCOPHARM)(BSE: 524816).
The two ANDA drug products are indicated for the prevention of nausea and vomiting associated with cancer chemotherapy, and have a combined current market size of approximately $360 million. Under the API Supply and Margin Sharing Agreement that was in signed April 2006, Natco will be responsible for the supply of active pharmaceutical ingredients for both drug products, while Akorn will be responsible for the manufacturing, regulatory submissions, marketing and distribution in the hospital, clinic, and home healthcare markets in the United States and Canada.
Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "We are excited to expand our business partnership with Natco Pharma. These two products will provide an excellent fit with our oncology product pipeline."
Rejeev Nannapaneni, Natco Pharma's Chief Operating Officer stated, "We are happy to take our cooperation to four projects now. This deal structure will enhance business opportunities in an increasingly competitive environment."
01/11/06 FDA Approves First Generic Metronidazole
ROCKVILLE, Md., Nov. 1, 2006-The Food and Drug Administration today approved the first generic version of MetroGel-Vaginal (metronidazole vaginal gel), a treatment for bacterial vaginosis. The approval is an important step in the agency's effort to increase the availability of lower-cost generic medications.
Bacterial vaginosis is a condition in women that is characterized by vaginal discharge and results from an overgrowth of bacteria in the vagina.
"This approval is another example of our agency's efforts to increase access to safe and effective generic versions of approved brand name drugs as soon as the law permits," said Gary J. Buehler, Director, and Office of Generic Drugs. "Metronidazole vaginal gel is a widely-used antibacterial preparation, and its generic version can bring significant savings to the millions of Americans with bacterial vaginosis." Metronidazole is an antibiotic effective against anaerobic (lacking oxygen) bacteria.
01/11/06 Paddock Wins Summary Judgment in Univasc Suit
Judge Ann D. Montgomery of the U.S. District Court for the District of Minnesota recently granted Paddock Labs' motion for summary judgment of noninfringement of Warner-Lambert's U.S. Patent No. 4,743,450, which covers pharmaceutical formulations of moexipril hydrochloride, the active ingredient in Univasc.
Warner-Lambert granted Schwarz Pharma an exclusive license under the '450 patent to manufacture and sell drug products containing moexipril hydrochloride, an Angiotensin Converting Enzyme (ACE) inhibitor indicated for the treatment of hypertension and congestive heart failure. Schwarz Pharma and Warner-Lambert sued Paddock Labs based on Paddock's ANDA to market a generic version of Univasc. Schwarz Pharma's U.S. sales of Univasc amounted to $80 million last year.
In her opinion granting Paddock's motion for summary judgment, Judge Montgomery rejected Paddock's assertion of argument-based prosecution history estoppel, but agreed with Paddock's assertion of amendment-based prosecution history estoppel. During prosecution, in order to overcome an obviousness rejection, Warner-Lambert amended claim 1 of the '450 patent from reciting an ACE inhibitor composition comprising "a metal containing stabilizer" to an ACE inhibitor composition comprising "an alkalai or alkaline earth metal salt." Judge Montgomery found this was a narrowing amendment made for reasons of patentability, raising a presumption of surrender of all equivalents of "metal containing stabilizers" that are not "an alkalai or alkaline earth metal salt"--including magnesium oxide, the alleged equivalent Paddock uses in its generic Univasc formulation.
The court further found that the plaintiffs failed to rebut the presumption by proving either that magnesium oxide was an unforeseeable equivalent or that the claim amendment was merely tangentially related to magnesium oxide. Accordingly, the court granted Paddock's motion for summary judgment of noninfringement.
In a last-ditch effort to avoid the finality of Judge Montgomery's opinion and order, last week Schwarz Pharma filed a motion to alter or amend judgment pursuant to F.R.C.P. 59(e). In its motion, Schwarz argues that it was legally and factually erroneous for the court to conclude that magnesium oxide was a foreseeable equivalent. Paddock Labs has not yet filed its opposition brief.
01/11/06 Synovics Initiates U.S. Development of Its Fourth Oral Generic
PHOENIX--(BUSINESS WIRE)--Nov 1, 2006 - Synovics Pharmaceuticals, Inc., a specialty pharmaceutical company with proprietary technologies for the development of oral controlled-release (OCR) generic and branded oral drugs, today announced that it has initiated the process for U.S. chemical, manufacturing and control (CMC) development of its fourth OCR generic drug candidate, SNG1004. Synovics is developing three doses of SNG1004 (a, b and c), which represent a generic formulation of a branded drug with annualized U.S. sales of approximately $1.5 billion. There currently is no approved generic for the OCR version of this drug.
Concurrently, Synovics intends to conduct pivotal studies in accordance with U.S. Food and Drug Administration (FDA) guidelines to confirm bioequivalency to the formulation and biostudies data previously conducted in India. Successful completion of development efforts are anticipated to result in the Company's filing of an Abbreviated New Drug Application (ANDA) with the FDA.
"Commencement of U.S. biostudies represents an important milestone as we advance our development program for difficult-to-formulate OCR generic drugs," said Ronald Howard Lane, Ph.D., Synovics Chairman and Chief Executive Officer. "We continue to execute on our business strategy of utilizing the low-cost, scalable manufacturing of our Kirk Pharmaceuticals subsidiary. In addition to CMC development of SNG1004, Kirk has already proved instrumental in steadily moving our first three OCR generic drug programs, which we initiated earlier this year, through the U.S. development process."