NewsBytes — Chain Pharmacy, 11/19/12
FDA approves Par leukemia drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.
Par said Oct. 25 that the FDA had approved Anchen Pharmaceuticals’ tretinoin capsules in the 10-mg strength.
The drug is a generic version of Roche’s Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.
Federal court orders FDA to allow Watson diabetes drug launch; Mylan challenges ruling
PARSIPPANY, N.J. — A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.
Watson said the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson, ruling that the FDA would have to approve its generic version of Takeda’s Actos (pioglitazone hydrochloride) tablets in the 15-mg, 30-mg and 45-mg strengths. Mylan is challenging the decision.
Mylan, the world’s second-largest generic drug maker, filed a motion to stay the court’s order. “Mylan is disappointed in [the] ruling regarding pioglitazone, and we believe the court erred in its decision by directly contravening the Hatch-Waxman Act,” Mylan CEO Heather Bresch said, referring to the 1984 law that created an abbreviated approval pathway for generic pharmaceutical drugs.
“Mylan does not believe Watson is entitled to participate in Mylan’s 180-day exclusivity period in relation to this product, and we intend to pursue this case vigorously, including seeking expedited relief from the appellate court if necessary.” Watson filed suit against the FDA in August 2012, alleging that an agency decision to deny Watson’s claim to shared exclusivity in marketing a generic version of Actos would improperly delay its launch of the drug. Actos had sales of about $2.7 billion during the 12-month period ended in May, according to IMS Health.
FDA approves generic Lupin
MUMBAI, India — The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said on Oct. 18.
Lupin announced the approval of Kurvelo (levonorgestrel and ethinyl estradiol) tablets in the 0.15 mg/0.03 mg strength.
The drug is a generic version of Teva’s branded Nordette. Nordette had sales of about $59 million during the 12-month period ended in June, according to IMS Health.
FDA approves Sandoz dermatology medication
PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Sandoz for treating symptoms of various skin diseases.
Sandoz, the generics arm of Swiss drug maker Novartis, announced the approval of desoximetasone ointment in the 0.25% strength. The drug is a generic version of Taro Pharmaceutical Industries’ Topicort and, according to Sandoz, is the first Fougera dermatology product Sandoz has launched since its $1.5 billion acquisition of the company in May 2012.
Topicort and its generic versions had sales of $36.5 million during the 12-month period that ended in August 2012, according to IMS Health.
Generics target specialty pharmacy with biosimilars
Perhaps the iconic scene at the end of Ridley Scott’s 1991 movie “Thelma & Louise” — with Gina Davis’ and Susan Sarandon’s characters hurdling into the Grand Canyon in a green convertible — is a good metaphor for what’s happening in the generic drug industry these days.
All right, maybe that’s a little too dramatic, but the so-called “patent cliff” is here. But unlike Thelma and Louise, it’s not too late for drug makers to adapt to an environment in which the supply of top-selling primary-care drugs with expiring patents begins to dwindle, leaving entire disease-state categories commoditized.
“Eventually, that patent cliff will not be there,” IMS Health VP industry relations Doug Long told Drug Store News. “When you have a brand innovation drought, particularly in primary care or pill forms, eventually that will create a generic small molecule opportunity drought, and that’s likely to happen at the end of the decade.”
The response for both generic and branded drug makers has been to move up the value chain, Long said, which includes moving into specialty drugs for diseases like cancer and autoimmune disorders.
According to IMS Health, the specialty drug market was worth $42.8 billion during the 12-month period ended in June, and according to Medco Health Solutions, now part of Express Scripts, specialty pharmacy costs could account for 40% of drug spending by 2020. So it should come as no surprise that a huge number of drug makers, retailers and others hope to grab a piece of it.
One of the ways generic drug makers hope to do this is with biosimilars. The Patient Protection and Affordable Care Act included a mandate for the Food and Drug Administration to create an abbreviated regulatory approval pathway for biosimilars, similar to the one for generic pharmaceutical drugs that the Hatch-Waxman Act created 28 years ago.
The regulations aren’t in place yet, but some drug makers aren’t content to wait — and some are seeking approval for biosimilars using the pathway for novel biologics already in place. At the end of August, the FDA approved Teva Pharmaceutical Industries’ tbo-filgrastim for treating neutropenia, a condition in which the number of white blood cells is decreased, making patients more susceptible to life-threatening bacterial infections. The company sought approval using a biologics license application, or BLA, the same approval pathway used for novel biotech drugs because while the Patient Protection and Affordable Care Act created a regulatory approval pathway for biosimilars, the regulations have not yet been established. Teva markets tbo-filgrastim in Europe under the trade name Tevagrastim, which is a biosimilar version of Amgen’s Neupogen. Teva plans to market tbo-filgrastim starting in November 2013, under an agreement with Amgen.
Another area of opportunity in the future will be oral solids for cancer. Most of those drugs are brand-new and won’t lose patent protection for at least a decade. “The chance for generic entry is some place off in the future, but then that will still follow the same pattern,” Long said.
Click here for the full 2012 Generics Report.
Branded generics transform the old into the new
In the classic Arabian Nights tale “Aladdin and the Magic Lamp,” the sorcerer who sold Aladdin the lamp containing the genie attempts to get it back by walking through the town where Aladdin and his wife live disguised as a merchant, trading “new lamps for old.”
Rubbing pill bottles isn’t likely to bring forth any genies ready to grant three wishes, but the idea of inputting something old and outputting something shiny and new is sort of the gist behind branded generics.
According to IMS Health VP industry relations Doug Long, “branded generics” has multiple meanings. One refers simply to generic drugs given brand names, such as a number of generic contraceptives on the market that carry brand names because calling them by their full generic names would be too cumbersome. Another kind of branded generic consists of a drug that has lost patent protection for which a drug maker develops a novel method of delivery to create a new drug. Last month, EffRx and Mission Pharmacal launched Binosto, which takes the generic osteoporosis drug alendronate sodium and reformulates it as an effervescent tablet that dissolves in water, a similar drug-delivery method to Alka-Seltzer.
The top-selling and probably best-known branded generic is Perdue Pharma’s OxyContin, an extended-release formulation of the generic opioid painkiller oxycodone. OxyContin itself is scheduled to start losing patent protection in April 2013.
Another use for off-patent molecules, Long said, is to pair them with another molecule to create a branded drug. Vintage Pharmaceuticals, for example, markets Percocet, which combines oxycodone and acetaminophen. Endo Pharmaceuticals, meanwhile, markets Percodan, a cross between oxycodone and aspirin.
In the meantime, branded drug makers will continue finding ways to get the most out of the drugs they’ve developed.
A long-standing practice has been what Long calls “incremental improvements,” like launching an extended-release formulation of an existing drug, but these efforts have been getting less successful, he said. Perhaps a similar approach is to come up with entirely new modes of delivery. United Therapeutics Corp.’s patents on the pulmonary arterial hypertension drug treprostinil — which it markets as the injected drug Remodulin and the inhaled drug Tyvaso — are expected to expire between 2014 and 2029, according to Food and Drug Administration records. Meanwhile, Sandoz, the generics arm of Swiss drug maker Novartis, is looking to market a generic version of Remodulin, though United Therapeutics filed a lawsuit against Sandoz in March to prevent it from launching. But in October 2012, United Therapeutics received a complete response letter from the FDA for a tablet formulation of treprostinil; a complete response letter means that the FDA has finished examining a regulatory application for a drug, but questions remain that preclude approval.
Click here for the full 2012 Generics Report.