The Pharmaceutical Research & Manufacturers of America will submit a review of antibiotics manufacturing capability to HHS Secretary Tommy Thompson by early next week, President Alan Holmer told a press briefing Oct. 26.

Thompson has "asked us to get back to him by early next week with respect to what is the antibiotic production capability of the companies and we will respond to this," Holmer told the briefing.

Holmer said Thompson made the request "recognizing that we have more than enough supply of medicines right now to be able to address anthrax, but looking beyond down the road."

Thompson also requested that "the pharmaceutical companies put together for him a pharmaceutical scientific technology taskforce," Holmer said.

"Our best scientists...will come here and meet with the secretary and his top scientists at the HHS, CDC, FDA and NIH to see how we can together meet the challenges that are coming forward," he said.

Lilly, Pfizer, Bristol-Myers Squibb, GlaxoSmithKline, J&J, Merck, Aventis, Abbott, Boehringer Ingelheim, Pharmacia, King and Ivax are among companies that have offered antibiotics to combat anthrax.

"Several of us have said that we have no intentions to make any profit on bioterrorism," Bristol's CEO Peter Dolan told the briefing. GSK Chief Operating Officer Robert Ingram said the company would supply antibiotics "without profit as an incentive."

Bristol is in discussions with FDA regarding an indication for Tequin (gatifloxacin) for use against anthrax.

The company has offered "to provide the antibiotic at no cost to any person who is confirmed to have anthrax infection or who has been exposed to anthrax spores and needs prophylactic treatment." Bristol's "offer on Tequin is matched by Glaxo's offer and J&J's offer," Dolan said.

In addition, Bristol said it would "consider sharing the Tequin license with the government or with other companies, after receiving all necessary approvals, in the unlikely event that the need exceeds the supply."

The offer of free product follows criticism of Bayer while it was negotiating a price with HHS for stockpile supplies of its anthrax antibiotic Cipro (ciprofloxacin)

J&J is seeking an indication for use against anthrax for Levaquin (levofloxacin). The company would "make available up to 100 mil. tablets free of charge to the federal government for use as it determines appropriate, assuming FDA approval" of Levaquin for anthrax.

J&J initiated discussions with FDA regarding the indication in June, the company noted. The Department of Defense Armed Forces Epidemiology Board has expressed an interest in the once-daily formulation of Levaquin (¹ Also see "BioPort Anthrax Vaccine Production Data To Be Submitted To FDA By Mid-Oct." - Pink Sheet, 24 September, 2001., p. 17).

J&J "is prepared to do whatever preclinical or clinical work is required by the agency and would address this with urgency so as not to impede the ability of the government to access this drug," the company said.

GSK is working with FDA on possible anthrax indications for its antibiotics Augmentin (amoxicillin/clavulanate) and Amoxil (amoxicillin), the company said.

Lilly is testing its oncologic agent Gemzar (gemcitabine) as a possible treatment for smallpox. The company also said it is evaluating its existing antibiotics franchise to identify agents that could be used against bioterrorism.

Abbott said it would offer Biaxin (clarithromycin) and erythromycin free of charge "if requested and approved by the U.S. government."

Animal studies conducted on Pharmacia's Cleocin (clindamycin) indicate efficacy against anthrax, the company said. "Zyvox [linezolid] and other antibiotics are in laboratory testing to determine efficacy against anthrax and other potential threatening agents," the company said.

Congress is working on initiatives that would expedite the review of products related to bioterrorism. The House Democratic proposal under the Bioterrorism Protection Act of 2001 would allocate $50 mil. towards FDA's fast-tracking of approval for bioterrorism vaccines and antibiotics.

Manufacturers of products with existing bioterrorism indications are increasing production as reports of anthrax exposure increase.

King has made preparations to double its output of the penicillin antibiotic Wycillin, the company said. King is also evaluating whether to seek anthrax indications for other approved products.

Pfizer said it increased production of Vibramycin (doxycyline). Ivax noted that it was awarded a contract by the government to supply about 1.2 bil. tablets of 100 mg doxycycline tablets and capsules.

Bayer will produce 100 mil. tablets of Cipro by the end of the year for HHS under a negotiated price of 95[cents] per tablet. The government previously paid $1.77 per tablet, the company said.

The $95 mil. contract would leave half of the company's increased production available for public sale. The company previously said that it has ramped up production of the anthrax treatment to produce 200 mil. pills in three months (² Also see "HHS Expects To Push Cipro Price To Generics Level Thru Bayer Negotiations" - Pink Sheet, 22 October, 2001., p. 11).

The significant attention paid to the government price of Cipro may influence negotiations with other purchasers.

Five generic companies have received tentative approval for ciprofloxacin. Ranbaxy and Barr indicated they would charge less than $1 per pill if the Cipro patent was overridden. Teva said it would offer ciprofloxacin at a competitive price with Cipro. Ivax' ANDA is also tentatively approved.

Bayer also agreed to donate 2 mil. Cipro tablets to HHS "for emergency workers working on the frontlines in the fight against anthrax," the firm said.

Under the deal, the government has the option to purchase an additional 200 mil. Cipro pills from Bayer.

Bayer said that it believes its patent for Cipro is "free of doubt" in the U.S. The company "has received multiple confirmation of its patent protection for the active substance ciprofloxacin in the United States and is therefore entitled to enforce these protective rights against all third parties...until the patent expires in December 2003."

Sen. Charles Schumer (D-N.Y.) had sought the override of Cipro's patent so the government could purchase cheaper generics.

During the negotiations between Bayer and HHS on a price for an increased stockpile of Cipro, Thompson had maintained that pricing, not availability, would be decisive in whether to override the patent.

"Price is the question," he told a House Government Reform/National Security Subcommittee Oct. 23. "I made that crystal clear to Bayer that we will not accept the price that they offered."

Industry and Hill Republicans emphasized supply, not pricing, concerns when discussing whether Cipro's patent should be overridden.

Sen. Bill Frist (R-Tenn.) told National Public Radio's "The Diane Rehm Show" Oct. 22 that discussions about breaking the Cipro patent in order to allow more rapid production of the drug to treat anthrax are premature.

"I believe it is way too premature - way too premature - where we are today to basically say that we need to turn the patent of Cipro over to people broadly to manufacture it," Frist said.

Frist noted that other antibiotics are just as effective as ciprofloxacin for use after anthrax exposure. "If you look at the anthrax that we've seen in the U.S., to date it has been 100% sensitive to not just Cipro, but also penicillin and doxycycline, to the other fluoroquinolones, to tetracycline [and] to a broad range of antibiotics," he said.

"I mention that because the world is focused on Cipro where in truth these other drugs are equally effective," he said. "The focus on Cipro has been really unbelievable."

The government should override the Cipro patent only if there is a clear shortage, PhRMA Senior VP-International Affairs Shannon Herzfeld said during the PhRMA press briefing on the World Trade Organization Ministerial Oct. 23.

"If there was a medical situation for which there was only one drug that worked and that drug was not available and the manufacturer wasn't able to supply it, then of course the U.S. government has the right to compulsorily license that," Herfeld said. But, "that's not the case now."

PhRMA Antibiotics Manufacturing Capability Review Requested By Thompson

More from Archive

More from Pink Sheet