ReportersNotebook — Chain Pharmacy, 9/19/11
EXECUTIVE NEWS — The Generic Pharmaceutical Association has named Ralph Neas as its new president and CEO. Neas, currently president and CEO of the National Coalition on Health Care, replaces Kathleen Jaeger, who stepped down as president and CEO of GPhA in May 2010 after eight years with the organization. The GPhA said it planned to spend September introducing Neas to stakeholders in a broad outreach effort.
Neas has worked closely with the generic drug industry over the last three years, promoting generics as a way of saving money while he led the NCHC, and the GPhA will be working with the NCHC’s Cost Containment Alliance.
SUPPLIER NEWS — Par Pharmaceutical will acquire Anchen Pharmaceuticals for $410 million, Par said. Based in Irvine, Calif., Anchen is a privately owned generic drug maker that expects to launch eight to 10 new generic drugs over the next two years.
Hi-Tech Pharmacal has acquired marketing and distribution rights for TussiCaps, available in 10-mg/8-mg and 5-mg/4-mg formulations, from Mallinckrodt. Hi-Tech’s ECR Pharmaceuticals subsidiary, which markets branded prescription products, will promote TussiCaps, the only extended-release prescription cough-cold capsule product approved by the Food and Drug Administration.
In related news, Hi-Tech also recently acquired the marketing and distribution rights to an abbreviated new drug application filing from KVK-Tech for an antihistamine/decongestant product — dexbrompheniramine maleate 6-mg/pseudoephedrine sulfate 120-mg extended-release tablets — which will be marketed by ECR under the brand name Lodrane.
Prasco will market an authorized generic drug for urinary tract infections under an agreement with Shionogi, the company said. Prasco announced that it signed a supply agreement with Shinogi to market and distribute nitrofurantoin oral suspension, an authorized generic version of Furadantin. Last month, the company contracted with Shionogi to sell an authorized generic version of the painkiller Ponstel (mefenamic acid).
Industry faces new issues concerning generic drug regulations
NEW YORK — While settlements constitute the most prominent patent-related issue for generic drugs, two others have cropped up this year as well.
In June, the Supreme Court said it would hear the case of Caraco Pharmaceutical Labs, Ltd. v. Novo Nordisk A/S, concerning Novo Nordisk’s Type 2 diabetes drug Prandin (repaglinide). Novo Nordisk had patent protection for the drug when combined with metformin, but not as a stand-alone therapy. Caraco sought approval of generic repaglinide for use alone, without metformin, under a provision of the Hatch-Waxman Act that allows the Food and Drug Administration to approve a generic version of a drug for approved uses not covered by any patent, allowing Caraco to avoid patent litigation. But Novo Nordisk changed its use code, a description of the patent required for FDA filing, to encompass use of Prandin alone, thus requiring the FDA to turn down Caraco’s approval application. Caraco filed a counterclaim requesting that Novo Nordisk be required to change the use code back to the original because its patents only cover Prandin in combination with metformin.
Another issue is the America Invents Act, introduced in March. The Generic Pharmaceutical Association has expressed opposition to a provision of the bill that it said would allow patent holders who knowingly falsify or omit information in their original patent applications to retroactively correct their filings without any consequences. Generic drug companies frequently use falsifications and omissions in patent applications as a basis for challenging the validity of patents when they wish to market a generic version of a drug prior to patent expiration.
Biosimilar path to take form by patent cliff
It’s hard to disagree that generic drug companies have had a good run for the last several years. Branded drug companies developed a large number of drugs that proved highly effective at treating widespread medical conditions and became blockbusters, garnering billions of dollars in sales in the United States alone. As patents on these blockbuster drugs have expired, they’ve provided generic manufacturers with enormous revenues, helping some to join the ranks of the world’s biggest drug companies.
Over the next few years, however, the party will come to an end as the number of blockbusters losing patent protection dwindles, part of what experts have come to call the “patent cliff.” While this will force many generic drug companies to merge, larger companies are looking to biosimilars.
The Affordable Care Act included a provision to create a regulatory approval pathway for biosimilars, though it turned out to be something of a pyrrhic victory for generics manufacturers because it would grant 12 years of market exclusivity to biotech drugs instead of the five years given to pharmaceuticals. Nevertheless, it brings biosimilars one step closer to the market.
“In terms of biosimilar drug manufacturers, there are huge opportunities because their biosimilar products have the potential to erode significant sales away from the branded agent,” Decision Resources analyst Andrew Merron told Drug Store News. “Biosimilars will target the most commercially successful branded biologics, and even if the biosimilar only manages to capture a small percentage of erosion from the major biologic blockbusters, sales could still be significant.”
IMS Health expected the global market for biosimilars to be between $1.9 billion and $2.6 billion by 2015, but its actual value — let alone the U.S. market’s value — remains uncertain. “That is a question that we are debating quite vigorously right now,” IMS Health VP industry relations Doug Long told DSN.
One major issue that remains is the form the regulations will take. The trouble with biosimilars, compared with generic pharmaceuticals, is that differences in the cells used to produce a reference product and those used to produce a biosimilar make it difficult to produce an exact copy, meaning that clinical trials will be necessary to determine that the latter is as safe and effective as the former. “The law has been passed; everybody’s waiting for the guidelines,” Long said. “When they will come out is anybody’s guess.” Still, Long said IMS expected them to hit the market in late 2013 or 2014.
Companies that already make biosimilars for the European market — Teva Pharmaceutical Industries, Sandoz and Hospira — are likely to be the first to market in the United States as well, Long said. In addition, Mylan and Watson have expressed an interest, but whether or not talk about making biosimilars will translate into action is unclear. With the costs of developing biosimilars estimated in the hundreds of millions of dollars, according to most analyses, the number of companies making them will probably remain small.
In terms of the first products, Long and Merron both said biosimilar versions of such drugs as Amgen’s Neupogen (filgrastim) and Neulasta (pegfilgrastim) — used to prevent infections in patients on chemotherapy — as well as epoetins would come before more complex treatments for cancers and autoimmune disorders, such as monoclonal antibodies. Teva applied last January for FDA approval of its versions of Neupogen and Neulasta, which it already markets in Europe. In the absence of an abbreviated approval pathway, it had to apply using a biologics license application — the same process used by branded biologics manufacturers — and Amgen has sought to block it. In July, Teva and Amgen reached a settlement that would allow Teva to launch its versions by November 2013.