Angiotech Pharmaceuticals Inc., unable to regain compliance with NASDAQ listing standards, is delisted from the exchange
Jan. 26, 2011: Angiotech Pharmaceuticals Inc.’s (OTC:ANPI) shares are no longer traded on NASDAQ as of today.
The Vancouver-based company failed to regain compliance with the stock exchange’s listing rules within a 180-day period that ended Jan. 3.
NASDAQ warned the company (PDF) in July about its requirement for a minimum bid price of $1 for listed securities.
ANPI shares were down about 1.6 percent for the day, closing at less than 21 cents.
Angiotech staked its fortunes to Boston Scientific Corp. (NYSE:BSX) and the Taxus drug-eluting stent for which Angiotech makes the drug paclitaxel, but it has has struggled with sales of the stent in the cellar and still falling.
Royalties from Taxus sales — Angiotech pulls in about 6 percent of net sales worldwide — were off by 50 percent during the three months ended on June 30, and 56 percent in the three months ending Sept. 30, when compared to the same periods the previous year.
The dropping revenues have added up for the company and it postponed payment of $9.7 million in interest on debt in November. The same month, the company reported disappointing earnings for its 2010 third quarter, posting a net loss of $18.5 million, or 22 cents per diluted share, on sales of $59.0 million during the three months ended Sept. 30. That compares with a loss of $7.8 million, or 9 cents per diluted share, on sales of $63.2 million during the same period last year.
Looking to put some eggs in baskets other than Boston Scientific’s, Angiotech is working with Athersys Inc. (NSDQ:ATHX) to develop MultiStem, a stem-cell-based cardiovascular treatment. In November the company entered a private label deal to supply Hologic Inc. (NSDQ:HOLX) with a soft tissue biopsy instrument. The company also signed a deal in November to offload its Lifespan vascular graft business to LeMaitre Vascular Inc. (NSDQ:LMAT) for $3 million.
Angiotech’s common shares will still be tradable on the Toronto Stock Exchange under the trading symbol “ANP,”according to the company.
Federal Government to Assist Pharmaceutical Developments
Jan. 25, 2011: National Institutes of Health has approved Obama’s decision to assist with funding for drug research and development through a Federal Research Center.
The Obama administration has decided to go forward with a decision to develop a drug development center. The announcement, initially made in December 2010, revealed that the administration was considering such a course. The goal of the center will be to research and create new medications, as the pace of drug development has slowed over the years.
The center will be known as the National Center for Advancing Translational Sciences. The government will be responsible for establishing, building, staffing, and maintaining the center. The undertaking will be a division of the National Institutes of Health (NIH).
According to reports from the National Institutes of Health, development of new drugs has been in a steady decline for the past fifteen years by pharmaceutical companies. The NIH board of directors voted to approve the creation of the new center as a means to spur drug development. The law prohibits the NIH from having more than 27 centers and institutions, so one will have to be dissolved to create the facility.
Estimates put the cost of developing a single medication to as much as one billion dollars. The administration anticipates investment dollars from drug companies to assist in paying for the venture.
Some citizens as well as politicians view moving drug research and development from the private industry to a government run venture as an assault on capitalism. With government spending at an all-time high, citizens are questioning why the President is backing such a costly business. Political blogs and message boards are active with citizens that are unhappy with the decision. There are also those who applaud the effort to jump-start the development of new medications.
Teva Receives FDA Action Letter For Generic Lovenox®
Jan. 25, 2011: JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that it has received correspondence from the U.S. Food and Drug Administration (FDA) regarding the Company’s abbreviated new drug application (ANDA) for generic Lovenox® (enoxaparin sodium) injection. The receipt of this action letter, called a Minor Deficiency letter, indicates that the FDA has completed its review of the ANDA including the Company’s responses to key questions during the review process. Prior to potential final product approval, the Office of Generic Drugs requires responses to a short list of questions, which Teva intends to respond to in the near future.
About Teva
Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world’s largest generic drug maker, with a global product portfolio of more than 1,250 molecules and a direct presence in approximately 60 countries. Teva’s branded businesses focus on neurological, respiratory and women’s health therapeutic areas as well as biologics. Teva’s leading innovative product, Copaxone®, is the number one prescribed treatment for multiple sclerosis. Teva employs more than 40,000 people around the world and reached $13.9 billion in net sales in 2009.
BioSante gets orphan status for skin cancer vaccine
Jan 25 (Reuters) – BioSante Pharmaceuticals Inc (BPAX.O) said its vaccine to treat skin cancer received orphan drug designation from U.S. health regulators, sending its shares up about 10 percent in pre-market trade.
The orphan drug designation for the melanoma cancer vaccine is the specialty pharmaceutical company’s fourth orphan drug designation for its portfolio of cancer vaccines, BioSante said in a statement.
It has already received orphan drug designations for its vaccines to treat pancreatic cancer, acute myeloid leukemia and chronic myeloid leukemia.
Melanoma is known to be the most serious form of skin cancer.
Orphan drug designation is granted by the U.S. Food and Drug Administration to drugs that treat a condition affecting less than 200,000 Americans, and gives the drugmaker marketing exclusivity of seven years in the country, upon approval.
Shares of Illinois-based BioSante were up at $2.05 in pre-market trading. They closed at $1.87 on Monday on Nasdaq. (Reporting by Rajarshi Basu in Bangalore; Editing by Maju Samuel)
FDA Panel to Vote on Risk of AEDs
Jan. 25, 2011: WASHINGTON — Injuries and deaths from malfunctioning automated external defibrillators (AEDs) could have been avoided if the devices were approved through a more stringent review process, FDA staff reviewers said.
On Tuesday, an agency advisory committee will vote on whether AEDs, now in the high-risk Class III device category, should be moved into a less-risky class, or remain where they are and be subject to the stringent premarket approval application (PMA) process.
Currently AEDs are allowed to enter the market through the 510(k) process, which allows device-makers to bypass the traditional approval pathway and show only that their product is substantially similar to one already on the market.
In 2009, the Government Accountability Office (GAO) recommended that the 510(k) process not be available for Class III devices. Such devices, the GAO said, should either be reclassified into the less-risky Class II category or be required to follow the PMA process.
In an analysis released Monday, FDA staff reviewers concluded that the devices should remain in the Class III category, given that AED malfunctions have been responsible for thousands of injuries and as many as 721 deaths over the past five years.
The low-energy devices — which analyze heart rhythm, identify whether it’s shockable or not, and either deliver or advise the operator to deliver an electrical shock — are now found in many public places, where they are intended for use by the general public on victims of sudden cardiac arrest.
The FDA reviewers noted that 300,000 people go into sudden cardiac arrest each year and, bystander use of AEDs saves 474 lives per year, according to a study published in the Journal of the American College of Cardiology.
But the FDA has received more than 23,000 reports of AEDs malfunctioning, including some instances where the devices failed to work at all and reports from manufacturers indicate there were 721 deaths resulting from AED malfunction between 2005 and 2010.
And there have been 68 recalls of AEDs in the past five year, affecting hundreds of thousands of devices, FDA reviewers wrote.
The FDA found that more than half of the recalls occurred because of incompatible device components, such as a manufacturer ordering a component that the vendor had changed, unbeknownst to the manufacturer. Nearly 40% of the recalls occurred because of design issues.
“The majority of recalls that have occurred since 2005 can be mainly attributed to issues associated with the firm’s handling of purchasing controls or design controls” FDA reviewers said.
The FDA staff also recommended the agency do a premarket review of AED manufacturer procedures, perform pre-approval inspections, review any changes in manufacturing facilities, and require manufacturers to annually report any changes in their manufacturing process or design.
The reviewers noted that there was a “minority FDA perspective” that AED technology is constantly evolving, and new versions of AEDS are being developed, so “future regulation under the PMA regulations may be overly restrictive and may slow the pace of improved AED technology reaching the marketplace.”
That minority view recommended reclassifying the devices to Class II, which allows for 510(k) clearance instead of a PMA.
Clinical Data gets FDA OK for depression drug
Jan. 25, 2011: NEWTON, Mass. Biotechnology company Clinical Data Inc. said Monday the Food and Drug Administration approved the major depressive disorder treatment Viibryd. Clinical Data shares surged more than 40 percent in pre-market trading.
The Newton, Mass, company said the drug should be available in U.S. pharmacies in the second quarter. Clinical Data holds exclusive worldwide rights to the drug from Germany-based Merck KGaA.
Major depressive disorder, also called major depression, is one of the most common mental disorders in the U.S.
Abbott’s Neck Stent Met Primary Goals in Study, FDA Staff Says in Report
Abbott Laboratories’s carotid stent met primary study goals for wider use, according to U.S. regulators weighing whether to expand the device’s approved use beyond patients who are too sick for surgery.
Clinical trials on the RX Acculink Carotid Stent “met the pre-specified criteria for study success,†Food and Drug Administration staff said in a preliminary review released today on the agency’s website. Outside advisers to the FDA will meet Jan. 26 to discuss the findings.
Abbott, based in Abbott Park, Illinois, is seeking to expand use of the device after a study last year concluded that carotid stents are as safe and effective as surgery. The FDA cleared its use in 2004 as an alternative treatment for patients at a high risk for complications from surgery to remove plaque from arteries that carry blood to the brain. Such blockages can lead to strokes if left untreated.
The advisory panel “will be asked to fully assess the significance†of the study findings, “and comment on the risk- to-benefit ratio,†the FDA staff said in today’s report.
Last year’s study, known as Crest and conducted in the U.S. and Canada, found that a stroke, heart attack or death occurred within 30 days in 4.5 percent of patients treated with Abbott’s stent, compared with 5.2 percent of surgery patients, researchers said. Strokes were more likely to occur in patients who received the stent, while heart attacks were more likely to occur in patients who had surgery, the study found.
Study Indicates Risks
The North American study, published in July in the New England Journal of Medicine, followed research in Europe that found carotid stenting to be riskier than surgery. Abbott’s Acculink competes with stents sold by Boston Scientific Corp., Johnson & Johnson, and Ev3 Inc.
The total U.S. market for carotid stents was about $70 million last year, Karene Dumoulin, an analyst with Millennium Research Group in Toronto, said Jan. 21 in an interview. The market may increase to $104 million in 2015 if the FDA approves the devices for more patients and Medicare coverage expands, she said.
About 795,000 people in the U.S. suffer a stroke each year, according to the Atlanta-based Centers for Disease Control and Prevention.
FDA says popular weight-loss products containing HCG are ineffective, fraudulent and illegal.
The agency is quoted by “USA Today” as saying while the products may not be dangerous, they are “economic fraud.”
It says there is no scientific evidence that HCG helps people lose weight.
The products are sold at general nutrition centers and are also heavily marketed on the internet.
The FDA says companies selling the products could be subject to enforcement action at any time.
HCG is a hormone approved only for treatment of conditions related to infertility.
Elizabeth Miller, head of the FDA’s Internet and health fraud team, told USA Today:
“We are aware of HCG products that claim to be homeopathic, but it is not recognized in the Homeopathic Pharmacopoeia.” Therefore, these products “are not recognized by the FDA as homeopathic drugs, so they are unapproved drugs and are illegal,” she says.
Optimer drug gets 6-month FDA review
Jan. 24, 2011: SAN DIEGO (AP) — Optimer Pharmaceuticals Inc. said Monday the Food and Drug Administration will give the company’s potential bacterial infection drug Fidaxomicin priority review.
Under priority review, the FDA aims to review a potential drug within 6 months instead of the usual 10-month period. Optimer expects an FDA decision by May 30.
Fidaxomicin is aimed at treating Clostridium difficile infection, which causes diarrhea and potentially life-threatening inflammation of the colon.
US generics demand to drive Indian pharma growth: Fitch
Jan. 24, 2011: Continued demand for generics from the US market will ensure stable outlook for Indian Generics Pharmaceuticals in 2011, global rating agency Fitch Ratings said on Monday.
However, liquidity will remain a concern for the sector, mainly due to working capital requirements, it added.
“The outlook for Indian generic pharmaceuticals for 2011 is stable. Earnings and profitability of Indian generic-based pharmaceutical companies will benefit from continued demand for generics,” the ratings agency said.
“Fitch expects the US market to be the main growth driver for the demand of generics,” it added. It said that Indian pharmaceutical companies expect about $ 96 billion worth drugs to go off patent in the US in 2011-2013.
The agency, however, said despite demand coming from European markets, “stiff pricing environment will limit exposure”.
It said that Indian pharmaceutical companies expect about $ 96 billion worth of drugs to go off patent in the US in 2011-2013.
On the mergers and acquisitions front, Fitch said it expects the trend to continue into 2011.
It said that attractiveness of Indian domestic market has been highlighted by acquisition of formulations business of Primal Healthcare by Abbott.
“Increasing interest towards generics among global innovator companies to either set shop in India [ Images ] or forge alliances and partnerships with Indian pharmaceutical companies will be additional revenue triggers for the sector,” it said.
Growth in domestic sales will continue to be aided by rising expenditure on healthcare, changing disease profiles on account of lifestyle-related diseases, and growing penetration in rural markets.
The domestic generics business has traditionally been the mainstay for Indian pharmaceutical companies. This will continue to be the profitable based on the growing domestic sector and increasing penetration on the rural market, it said.
Fitch expects working capital levels for the sector to remain high, which could have a negative impact on the liquidity profiles of smaller pharmaceutical companies.
It further cautioned that regulatory risks emanating from quality issues, litigation risks relating to alleged patent infringements and disputed ‘first-to-file’ can change the outlook to negative.
The strength of Indian companies remain the robust product outline and infrastructure and their focus on niche product segments and choosing high-value and low competition products to break through the US markets, it said.
Teva Obtains $1.5 Billion Credit Line to Refinance
Jan. 24 (Bloomberg) — Teva Pharmaceutical Industries Ltd., the world’s largest maker of generic drugs, said it got a $1.5 billion credit line to refinance debt at more favorable terms.
Citigroup Inc. and HSBC Holdings Plc are coordinators and bookrunners of the three-year unsecured revolving credit, the Petah Tikva, Israel-based company said today in a statement.
“This facility is part of our financial strategy to secure liquidity for future business needs through revolving credit lines,†Teva Chief Financial Officer Eyal Desheh said in the statement.
Banks halved the interest margin on loans to European borrowers with the same credit ratings as Teva’s to an average 73 basis points last year, according to data compiled by Bloomberg. Standard & Poor’s rates Teva’s debt A-. Moody’s Investors Service ranks it A3.
Barclays Capital, BNP Paribas SA, Credit Suisse Group AG, Goldman Sachs Group Inc., JPMorgan Chase & Co., Morgan Stanley, Bank Hapoalim BM and Bank Leumi Le-Israel Ltd. joined as lenders to Teva during the deal’s syndication.
Money in a revolving credit can be borrowed again once it’s repaid; in a term loan, it can’t. A basis point is 0.01 percentage point.
Acorda’s MS Drug Fails To Get Approval
Jan. 22, 2011: A European regulatory committee has refused its approval for Acorda Therapeutics’ multiple sclerosis drug already approved by US regulators. The European committee questioning the effectiveness of the drug that aims to improve walking in MS patients, failed to be convinced over Famprya’s ‘small effect’ on walking speed being of any meaningful benefit to patients, neither was it convinced of the effect on speed linked to better co-ordination, balance or stamina.
The drug is sold in USA under the name of Ampyra, generating $141 million in revenue last year for Acorda after its March debut. Biogen Idec Inc. holds the rights to sell Ampyra under the name of Fampyra in Europe, with Acorda receiving royalty and milestone payments from those sales.
The opinions of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) are usually followed by Europe’s drug regulator.
The rejection has come as a huge blow to Accorda that has been suffering from lagging research and development productivity in recent years.
Biogen is planning to appeal against the opinion, including asking for re-examination, which should take around seven months.
Approve in USA last year, Acorda signed a partnership for Biogen to market and develop its new drug, also known as fampridine-SR outside the U. S.
A twice-daily pill, the drug is used in addition to more mainstream MS therapies, and while Ampyra does not actually treat the disease, it is useful in conducting the electric signals that travel through nerves damaged by the condition.
BioCryst Pharmaceuticals CFO to step down
Jan, 21, 2011: BioCryst Pharmaceuticals Chief Financial Officer Stuart Grant has given notice that he is resigning from the drug developer.
Durham, North Carolina-based BioCryst (NASDAQ:BCRX) disclosed Friday in a filing with the U.S. Securities and Exchange Commission that Grant wishes to spend time this year traveling with his family following the loss of his son last year. Grant’s resignation is effective May 31 and the company said that he will be involved in the selection of his successor and the transition of his responsibilities to that person. After his resignation, Grant is also expected to continue his relationship with BioCryst through a consulting agreement. Grant has been BioCryst’s CFO since August 2007.
BioCryst is developing a flu treatment called Peramivir through a $180 million contract from the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health & Human Services. BioCryst, founded in Birmingham, Alabama, relocated its headquarters to Durham, where the company had much of its R&D operations.
Watson Pharma expects 2011 generic, branded growth
Jan, 21, 2011:
NEW YORK (AP) — Drugmaker Watson Pharmaceuticals Inc. said Friday it expects 2011 global revenue to climb in both its generic and branded segments, following a year in which net revenue grew 25 percent.
The Corona, Calif., company said it expects adjusted earnings per share between $3.85 and $4.15 on revenue of about $4.2 billion in 2011.
Analysts polled by FactSet expect, on average, earnings per share of $4.16 on about $4.15 billion in revenue.
Watson expects global generics revenue to grow to between $2.8 billion and $3 billion in 2011, up from an expected total of $2.35 billion last year. It anticipates global brand revenue of $470 million to $490 million in 2011, up from an expected total last year of $400 million.
The company’s 2011 launches include a generic version of the Johnson & Johnson attention deficit hyperactivity disorder drug Concerta. Under an agreement that runs until the end of 2014, J&J will be the supplier for the “authorized” generic product and will receive a share of the net sales.
Shares of Watson Pharmaceuticals climbed 82 cents to $53.69 in afternoon trading.
Sanofi’s Multaq Put Under Review in Europe
Jan. 21, 2011: PARIS—European drug regulators Friday launched a review of French drugs giant Sanofi-Aventis‘ heart treatment Multaq following two cases of acute liver failure in patients taking the drug.
The European Medicines Agency said its Committee for Medicinal Products for Human Use will conduct the review. The investigation in the worst case could result in the withdrawal of the drug’s authorization for use in Europe.
Multaq, a treatment for irregular heartbeats, is an important new product for the pharmaceutical company, which needs new products to replace key medicines that are losing patent protection and face competition from cheaper generic substitutes.
Such EMA investigations on authorized drugs, known as Article 20 procedures, generally take a couple of months depending on the amount of data available. They determine whether the regulator should maintain, change, suspend or even withdraw a drug’s authorization. The drug regulator’s committee will review existing information to weigh the benefits and risks of the drug.
Sanofi on Friday said it will send European health-care professionals a letter detailing the two liver failure cases and give recommendations on liver function testing for patients who have been prescribed the drug.
“We confirm we are issuing the letter as of today,” a company spokesman said Friday. He added that the prescribing information on Multaq will be revised to include the guidance in the letter, once it has been reviewed and approved by the European Medicines Agency.
Sanofi sent out a similar letter to health-care professionals in the U.S. last week.
The U.S. Food and Drug Administration required that labels for the drug include warnings of a possible liver risk. European authorities were expected to follow suit.
The European Medicines Agency earlier Friday said that the committee recommended changes to the drug’s product information to help manage the possible risk of severe liver complications.
While the two patients requiring a liver transplant were also taking other medications, the EMA committee said a causal relationship with Multaq could not be excluded and called for “urgent regulatory action” to help manage a possible risk of liver complications.
Multaq was first launched in 2009, and is sold in 16 countries in Europe, as well as in the U.S. and Canada. In the first nine months of 2010, Multaq sales totaled €109 million ($147 million).
FDA directs MannKind to conduct 2 new studies on inhaled insulin
Read more: http://www.allheadlinenews.com/briefs/articles/90031463?FDA%20directs%20MannKind%20to%20conduct%202%20new%20studies%20on%20inhaled%20insulin#ixzz1BgkgOWCr
Jan. 20, 2011: The U.S. Food and Drug Administration asked on Wednesday MannKind to conduct two new studies on inhaled insulin for Type 1 and Type 2 diabetics. With the FDA order, the company will have to delay the drug’s release in the market by 18 to 24 months.
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The drug is the first product of MannKind, founded by billionaire inventor Alfred Mann.
MannKind said it has started new studies and will meet with the regulatory agency to make sure the company satisfies the FDA requirements.
Dr. David Klonoff, the medical director of the Mills-Peninsula Diabetes Research Institute told the FDA in one hearing that inhaled insulin, along with oral, buccal, nasal and transdermal insulin, are some of the promising technologies to get insulin into a person’s body other than through a needle. Diabetes patients who inhale insulin absorb it rapidly, similarly to the action of intravenous fluid.
Several devices had been created by companies attempting to secure FDA approval of inhaled insulin, In one device, powdered insulin is placed inside a container similar to a asthma spray device. At the press of a button, air comes in and disburses the insulin into a cloud.
In another device, an insulin blister strip is inserted inside a device. When the mouthpiece of the device is rotated, a pin pricks the blister strip, which shoots an aerosol of liquid insulin.
Klonoff added that oral insulin would be a good alternative, but pharmaceutical companies must be able to make an insulin pill which would avoid the acidic degradation of the stomach, but preserve the strength of the insulin molecule.
This is the second delay in Mannkind’s FDA application. The first was initially set on Dec. 29. Aside from MannKind, the FDA also postponed a decision on Afrezza’s application pending submission of updated safety data.
Read more: http://www.allheadlinenews.com/briefs/articles/90031463?FDA%20directs%20MannKind%20to%20conduct%202%20new%20studies%20on%20inhaled%20insulin#ixzz1BgkTlGGE
Burke Pharmaceutical Research tests topical treatment for head lice
Jan. 20, 2011: HOT SPRINGS, Ark. (KTHV) — The U.S. Food and Drug Administration has approved a drug tested in a Hot Springs clinic to eliminate head lice.
Head lice is the second most, infectious disease among children, next to the common cold.
A new drug for lice is coming to the market and a Hot Springs physician spear-headed the research.
The U.S. Food and Drug Administration approved the drug on Tuesday. Head lice are tiny insects that feed and live on the human scalp. They are irritating and can be embarrassing.
“You truly feel like you have bugs crawling in your hair,” says Marci Lawson.
Lawson and her three daughters tried all types of medications.
Hot Springs dermatologist Doctor Dow Stough tested the drug Natroba on Lawson’s family. The lead researcher found it eradicated the bugs and its eggs or nits.
“Eighty four percent of patients only needed a single application and they didn’t have to use a nit comb or pick out the nits,” says Dr. Stough.
Stough says lice have developed resistance to current medications and less than half of patients who use other drugs get rid of the pests.
“It didn’t require combing or require us to do our bedding or spray our house down,” says Lawson.
Natroba is easy to apply. You put it on your scalp for ten minutes. You wash it out and then you’re done.
“I think it will change the way head lice treatment is currently conducted,” says Dr. Stough.
Stough and his medical team tested it on more than one thousand patients. He says the product is safe and has very little side effects.
“A little bit of scalp irritation and scalp redness was noted in three percent,” says Stough.
Overall they found positive results. Patients like Lawson stand by it and it can now go on the market.
A doctor has to prescribe Natroba. Indiana company ParaPro invented the product and hopes to put it on the market the first half of this year.
Drug Firms Want Patent Documents Kept Secret
Jan. 19, 2011: Pfizer Inc., Merck & Co. and 35 other pharmaceutical companies have asked a federal judge to block the release of confidential documents detailing drug-patent litigation settlements, which Cephalon Inc. has requested as part of an antitrust dispute with the government.
Pfizer, Merck and the other companies say the settlement documents were submitted to the U.S. Federal Trade Commission under laws designed to ensure they would remain confidential.
“Disclosure of these settlement agreements and related documents in this matter would seriously damage the third parties’ business and legal interests,” the companies wrote in a motion filed this week in federal court in Philadelphia.
The FTC in December notified several drug makers that the commission could be forced to disclose the documents as a result of Cephalon’s request.
Cephalon had asked Judge Mitchell Goldberg last month to order the FTC to release the documents, saying it needs them to mount a defense against an FTC lawsuit that seeks to clear the way for generic competition for the company’s top-selling drug, narcolepsy treatment Provigil.
The FTC sued Cephalon in 2008, accusing it of buying off four generic-drug manufacturers, including Teva Pharmaceutical Industries Ltd., in settlements of patent-infringement litigation surrounding Provigil, which generates roughly half of Cephalon’s revenue.
The patent settlements, in which Cephalon paid a total of $200 million to the generics manufacturers, forestalled competition from cheaper copycats of Provigil until 2012.
The drug generated $828 million in sales for the first nine months of 2010; full-year results haven’t been reported. The FTC has asked a federal judge in Philadelphia to overturn the settlements, arguing they are anticompetitive. Private drug buyers also have sued Cephalon, which has denied the allegations.
The suit against Cephalon is part of the FTC’s multiyear campaign against what it calls “pay-for-delay” deals, in which makers of brand-name drugs effectively pay generics manufacturers not to launch cheaper copycat versions until a later date. The commission argues such deals are anticompetitive and deprive consumers and drug-benefit plans of cheaper options.
The drug industry argues patent-litigation settlements are permitted by law, and sometimes provide for the availability of generic drugs before scheduled patent expirations for brand-name drugs. Appellate courts have upheld the deals in recent years despite the FTC’s position.
Cephalon, of Frazer, Pa., says that in the course of the litigation, the FTC has cited conclusions from two reports it has published on patent settlements, including one issued a year ago that estimated drug buyers would save about $3.5 billion annually if Congress banned pay-for-delay deals. The study was based on patent-settlement agreements companies filed with the FTC between 2004 and 2009, as required by law.
In 2008, Pfizer reached a patent settlement with generics manufacturer Ranbaxy Laboratories Ltd., granting Ranbaxy a license to sell generic versions of blockbuster cholesterol drug Lipitor beginning in November 2011. Ranbaxy had previously tried to overturn key U.S. patents for Lipitor in an effort to sell generic copies sooner. However, Pfizer and Ranbaxy have said their agreement didn’t contain any payments that would run afoul of the FTC, and the commission hasn’t publicly challenged the deal.
Cephalon wants Judge Goldberg to either bar the FTC studies from being used in the case or to compel the FTC to turn over documents supporting the studies.
The FTC said in a court document this week that it has no intention of offering the studies into evidence. The commission objects to the release of the confidential agreements, saying they are irrelevant to the case and protected from disclosure by law. Cephalon has countered that the documents would only be disclosed to the judge and parties to the case for use in the litigation.
An FTC spokesman declined to comment.
Spokesmen for Merck and Cephalon couldn’t immediately be reached. A Pfizer spokesman declined immediate comment.
