Pfizer inks generics deal with Chinese drug maker
NEW YORK — Pfizer has signed a deal worth more than $500 million with a Chinese drug maker to make generic drugs for China and other markets, the companies said.
Pfizer announced the joint venture with Zhejiang Hisun Pharmaceutical to develop, manufacture and commercialize generic drugs. Hisun will invest $295 million into the venture — called Hisun Pfizer Pharmaceutical Co. — and own a 51% stake, while Pfizer will invest $250 million and own 49%.
The signing of the deal took place at the Sino-U.S. Economy & Trade Forum in Los Angeles during the visit of Chinese vice president Xi Jinping, who is widely expected to become China’s next president when current president Hu Jintao steps down this year.
ReportersNotebook — Chain Pharmacy, 2/27/12
SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.
The FDA has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said. The FDA approved Novartis’ Gleevec (imatinib) for adults who have had gastrointestinal stromal tumors, or GIST, removed. The drug was specifically approved for people whose tumors are known as CD117-positive, which includes 95% of all GIST tumors. The drug was originally approved in 2001 for a type of leukemia.
Takeda Pharmaceutical has launched a drug for treating high blood pressure in adults, the company said. Takeda announced the availability of Edarbyclor (azilsartan medoxomil and chlorthalidone), a once-daily tablet for hypertension.
The FDA has approved a head lice treatment made by Sanofi, the drug maker said. Sanofi announced the approval of Sklice (ivermectin) lotion in the 0.5% strength for patients ages 6 months and older. According to Sanofi, head lice affects an estimated 6 million to 12 million children ages 3 to 11 years and costs as much as $1 billion in lost school days and lost work for parents.
The FDA has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said. Mylan announced that it had received tentative approval for a generic version of Pfizer’s Lipitor (atorvastatin calcium) in the 10-mg, 20-mg, 40-mg and 80-mg strengths. A tentative approval means that the drug meets the FDA’s conditions for approval, but the agency can’t give final approval because of outstanding patent- and exclusivity-related issues. Ranbaxy Labs, which won approval for the first generic version of the drug in November, currently has the exclusive right to compete with Pfizer’s version and will until May. Lipitor had sales of $8.2 billion in 2011, according to IMS Health.
COPD pipeline grows despite patent cliff
One of the main plotlines of the big story called the drug industry over the past several years has been the patent cliff, the steady loss of patent protection on blockbuster primary care drugs and subsequent generic competition that has forced many drug companies to find new revenue streams. Much of this has taken place in the form of a gradual shift to specialty drugs for such conditions as cancers and autoimmune disorders, but recent developments have shown that primary care drugs may still have some steam left in them.
One market that still seems to be doing fairly well is chronic obstructive pulmonary disorder, which comprises emphysema and chronic bronchitis. The disease affects more than 13 million Americans, and an additional 12 million may have it without knowing it, according to the National Institutes of Health. In addition, it’s the third-leading cause of death, claiming the lives of more than 120,000 Americans each year.
In response, drug development has continued at a brisk pace. According to the Pharmaceutical Research and Manufacturers of America, more than 50 drugs are currently in clinical development for treating COPD, ranging from pharmaceutical drugs to stem-cell therapies that attack the biological mechanisms behind the disease.
Some new drugs for the condition already have hit the market. In October 2011, the FDA approved Boehringer Ingelheim’s Combivent Respimat (ipratropium bromide and albuterol sulfate), which is delivered in a propellant-free inhaler that uses a slow-moving mist to deliver the same active ingredients as the Combivent Inhalation Aerosol. The company expects to launch the drug in the middle of this year.
In November, generic drug maker Mylan bought rights to a drug delivery platform made by Pfizer that would allow it to manufacture and commercialize generic versions of GlaxoSmithKline’s Advair Diskus and Seretide Diskus (fluticasone propionate and salmeterol).