What follows below is a review of some of the pharma news stories that caught my attention during the month of April 2014. We also published several articles on topics of interest to those in the biotech and pharma world. Please see Compulsory Licenses Won’t Solve a Healthcare Crisis (written by Dr. Kristina Lybecker), Patents, Drugs and the Moral High Ground (written by Gene Quinn) and Leveraging Spin-Out Companies to Support Global Health (written by Erik Iverson, President of the Infectious Disease Research Institute).
- Avanir Pharmaceuticals Prevails in NUEDEXTA Patent Trial
- Actavis Net Revenue Increases 40% to $2.66 Billion in First Quarter 2014
- Actavis Announces Celebrex® Patent Challenge Settlement
- TWi Announces Settlement of Lidoderm(R) Patent Litigation
- Supreme Court Denies Teva’s Request for an Injunction Relating to Generic Copaxone®
- FDA Approves Sublingual Tablet for the Treatment of Short Ragweed Pollen Allergies
- Court Enforces Settlement Agreement Between Mylan and Endo Regarding Generic FROVA®
Avanir Pharmaceuticals Prevails in NUEDEXTA Patent Trial
On the afternoon of April 30, 2014, Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced via press release that the U.S. District Court for the District of Delaware has ruled in favor of Avanir in the company’s patent infringement lawsuit against Par Pharmaceuticals, Inc. and Impax Laboratories, Inc. in conjunction with their Abbreviated New Drug Applications (‘ANDAs’) for generic versions of NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) capsules for the treatment of pseudobulbar affect. On this news the company’s stock, which was trading at $3.33, jumped to just over $5 a share before settling back a bit. As of the writing of this article shares of AVNR are now trading at $4.65.
Following a six day bench trial in the District of Delaware, Judge Leonard P. Stark issued a ruling upholding the validity of the patents covering NUEDEXTA (US Patent Nos. RE38,115, 7,659,282 and 8,227,484), and holding that the proposed ANDA formulations infringe the claims of the ‘282 patent and ‘484 patent.
“We are very pleased with the Court’s decision, as it confirms our continued belief in the strength of the patents covering NUEDEXTA,” said Keith A. Katkin, president and chief executive officer of Avanir. “Our focus remains on making NUEDEXTA available to patients suffering from the debilitating condition of PBA. This decision provides twelve-plus years of market exclusivity for NUEDEXTA.”
NUEDEXTA remains the only FDA-approved product for the treatment of pseudobulbar affect.
Actavis Net Revenue Increases 40% to $2.66 Billion in First Quarter 2014
On April 30, 2014, generic drug maker Actavis plc (NYSE: ACT) reported net revenue increased 40 percent to $2.66 billion for the first quarter ended March 31, 2014, compared to $1.90 billion in the first quarter 2013. On a non-GAAP basis, diluted earnings per share for the first quarter 2014 increased to $3.49, compared to $1.99 per diluted share in the first quarter 2013. GAAP earnings per diluted share for the first quarter 2014 were $0.55, compared to a GAAP loss per share of $0.79 in the prior year period.
For the first quarter 2014, adjusted EBITDA increased 86 percent to $860 million, compared to $464 million for the first quarter 2013. Cash flow from operations for the first quarter of 2014 was $440 million and cash and marketable securities were $340 million as of March 31, 2014.
First quarter 2014 results for Actavis plc include the contribution from the Warner Chilcott acquisition. Beginning with the first quarter of 2014, Actavis plc is presenting its operating results in two revenue producing segments: Actavis Pharma and Anda Distribution. The Actavis Pharma segment includes all branded, branded generic, generic and over-the-counter products. The Anda Distribution segment includes revenue from the distribution of third-party products primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and physicians’ offices. Prior year comparable results have been included. Refer to the attached reconciliation tables for adjustments to GAAP earnings.
Actavis Announces Celebrex® Patent Challenge Settlement
On April 24, 2014, Actavis plc (NYSE: ACT) announced that it has entered into an agreement with Pfizer, Inc. (NYSE: PFE) to settle all outstanding patent litigation related to Actavis’ generic version of Celebrex® (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules. Celebrex® is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults.
Under the terms of the agreement, Pfizer will grant Actavis a license to market its generic Celebrex® beginning in December 2014, or earlier under certain circumstances. Other details of the settlement were not disclosed.
Launch of Actavis’ product is contingent upon Actavis receiving final approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for generic Celebrex®.
At the time of the announcement of the settlement of the Celebrex® patent litigation, Actavis said it believed it was the “first applicant” to file an ANDA for the generic version of Celebrex®. This is significant because if Actavis truly was the first applicant to file an ANDA if its ANDA is ultimately approved they would be entitled to 180 days of generic market exclusivity or shared exclusivity, subject to the FDA’s determination that the product qualifies for an award of exclusivity under the provisions of the Hatch-Waxman Act.
Unfortunately for Actavis, on April 28, 2014, the FDA awarded sole exclusivity on generic Celebrex® to Teva Pharmaceutical Industries Ltd. This prompted Actavis subsidiary, Watson Laboratories, Inc., to file a lawsuit suit against the U.S. Food and Drug Administration (FDA) challenging the Agency’s decision regarding its entitlement the 180-day marketing exclusivity for its generic version of Celebrex® (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules. Actavis argues that an earlier ruling from the U.S. Court of Appeals for the Federal Circuit resulted in the triggering and subsequent expiration of Teva’s sole exclusivity on the product.
For the 12 months ending December 31, 2013, Celebrex® had total U.S. sales of approximately $2.2 billion, according to IMS Health data.
TWi Announces Settlement of Lidoderm(R) Patent Litigation
TWi Pharmaceuticals, Inc. today announced that it has entered into a settlement agreement with Endo Pharmaceuticals Inc., Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA, Inc. to settle all outstanding patent litigation related to TWi’s lidocaine topical patch 5% product. An Abbreviated New Drug Application (ANDA) for TWi’s product is currently under review at the U.S. Food and Drug Administration (FDA). If approved, TWi’s product would be a generic version of Endo’s Lidoderm®.
The settlement agreement allows TWi to launch its generic Lidoderm® product on or after March 1, 2015, if the product is approved by the FDA. The agreement also provides for an earlier launch date under certain circumstances. Pursuant to the agreement, the litigation on this matter, currently pending in U.S. District Court for the District of Delaware, will be dismissed. Other terms of the settlement agreement were not disclosed.
The settlement agreement is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
Lidoderm® is indicated for relief of pain associated with post-herpetic neuralgia. For the 12 months ended December 31, 2013, the product had total U.S. sales of approximately $1.2 billion, according to IMS health data.
Supreme Court Denies Teva’s Request for an Injunction Relating to Generic Copaxone®
On April 18, 2014, Mylan Inc. (NASDAQ: MYL) announced that Supreme Court Chief Justice Roberts has denied Teva’s application for an injunction seeking to prevent Mylan’s launch of a generic version of Copaxone® pending the Supreme Court’s decision on Teva’s appeal. This is the second time that the Chief Justice has denied Teva’s request for such an injunction.
In March, the Supreme Court granted Teva’s petition for certiorari seeking clarification of the standard of review that appellate courts should apply when considering appeals relating to the construction of a patent claim. Oral argument is expected to be heard in the fall of 2014.
Mylan CEO Heather Bresch commented: “We are pleased with the Chief Justice’s decision, and we look forward to introducing the first generic Copaxone® treatment for multiple sclerosis patients in the U.S. at market formation. Mylan remains eligible to receive approval from the U.S. Food and Drug Administration on May 25, 2014.”
Meanwhile, United States Patent and Trademark Office recently issued a final office action rejecting Teva’s application seeking a reissue of U.S. Patent No. 5,800,808 (the “‘808 Patent”), which was found to be invalid by the Court of Appeals for the Federal Circuit in July 2013. The final rejection issued on April 3, 2014, finds the first claim of the reissue application, which is identical to the only claim in the ‘808 Patent, to be indefinite and both claims of the reissue application to be unpatentable based on obvious-type double patenting.
FDA Approves Sublingual Tablet for the Treatment of Short Ragweed Pollen Allergies
On April 17, 2014, Merck (NYSE: MRK), announced that the U.S. Food and Drug Administration (FDA) has approved RAGWITEK™ (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use (12 Amb a 1-U). RAGWITEK is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. RAGWITEK is approved for use in adults 18 through 65 years of age. RAGWITEK is not indicated for the immediate relief of allergic symptoms.
The prescribing information for RAGWITEK includes a boxed warning regarding severe allergic reactions. RAGWITEK is contraindicated in patients with severe, unstable or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.
“RAGWITEK provides a new sublingual approach to allergen immunotherapy for adult patients suffering from moderate to severe ragweed pollen allergies who have declined allergy shots,” said Dr. David Skoner, director, Division of Allergy and Immunology, Allegheny Health Network, and a clinical investigator in Merck’s sublingual allergen immunotherapy tablet program. “While there are regional variations, ragweed season typically starts in mid-August across the United States. During the season, many patients with moderate to severe allergic rhinitis experience nasal and ocular allergy symptoms at their worst while taking symptom-relieving medication. These patients often have multiple sensitivities. To help prepare for the upcoming ragweed season, I would encourage patients diagnosed with ragweed pollen allergies to make an appointment now with an allergy specialist to discuss options.”
Symptoms of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis may include sneezing, a runny or itchy nose, stuffy or congested nose, or itchy and watery eyes, and typically intensify during the ragweed pollen season.
Meanwhile, on April 14, 2014, Merck also announced that the approved GRASTEK® (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use [2800 Bioequivalent Allergy Units (BAU)]. GRASTEK is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. GRASTEK is approved for use in persons 5 through 65 years of age. GRASTEK is not indicated for the immediate relief of allergic symptoms.
Court Enforces Settlement Agreement Between Mylan and Endo Regarding Generic FROVA®
On April 11, 2014, Mylan Inc. (NASDAQ: MYL) confirmed that a federal district court granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan’s filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Frovatriptan Succinate Tablets, 2.5 mg. This product is the generic version of FROVA®, which is used to treat acute migraine headaches in adults.
As a result of the decision, the Court has vacated its January 28, 2014, decision in favor of Endo regarding the parties’ patent litigation over this product, which could have prevented Mylan from launching its generic version of FROVA until after the expiration of U.S. Patent 5,464,864 patent on November 7, 2015. By enforcing the settlement, Mylan can launch its product pursuant to the terms of the settlement, contingent upon final FDA approval.
For the 12 months ending Dec. 31, 2013, Frovatriptan had U.S. sales of approximately $66.41 million, according to IMS Health.
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