India’s big generic drugmaker is expected to form an alliance with the beleaguered drug giant that could generate up to $100 million in revenue for Ranbaxy, according to LiveMint, which cites an unnamed senior exec. [UPDATE: This deal was confirmed on Monday, May 12 and described as a $100 million deal].

The agreement would come nearly a month after Malvinder Singh, Ranbaxy’s managing director, indicated that such a deal was in the making, without naming the partner. Singh couldn’t be immediately reached for comment and a Ranbaxy spokesman declined to say anything to LiveMint. A Merck spokesman tells Pharmalot that the drugmaker won’t comment on “speculation.”

“The tie-up will be on the lines of what we have with GSK (Glaxo) and it will start from early-stage development to as far as phase II trials. It will span a range of therapeutic categories, though the focus will be on anti-infectives,” the unnamed senior exec tells LiveMint.

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In December 2003, Abbott Labs raised the price of its Norvir AIDS drug, which is commonly used in HIV drug cocktails, by 400 percent, creating a firestorm in the AIDS community. The mark-up prompted the Service Employees International Union Health & Welfare Fund to file a class-action lawsuit the next year that alleges the price hike violated antitrust laws.

How so? Abbott sells a combo pill called Kaletra that includes Norvir and its own protease inhibitor. The lawsuit claims Abbott raised Norvir’s price - but not the Kaletra price - in order to boost Kaletra sales at the expense of other protease inhibitors that require Norvir as a booster. In other words, Abbott allegedly tried to use Norvir to create a monopoly over the market for protease inhibitors.

The maneuver caused outrage - shareholder resolutions, protests at Abbott headquarters, a boycott by hundreds of docs, Attorney General investigations, and numerous editorials criticizing the increase. Last month, Abbott asked a federal court to seal numerous documents, citing confidentiality, and a judge acquiesced - to a point. Some documents were released in full; others were redacted. As a result, we are left with an incomplete picture of the thinking among Abbott execs.

However, one document seems to indicate at least one person at Abbott worried that a price hike would spur federal investigations, apparently because the drugmaker lacked a justification to charge more for Norvir. This was contained in an e-mail from Abbott exec Jesus Leal, who discusses three strategies that Abbott considered to drive up Kaletra sales. You can read that here.

For a closer look at the released documents, you can visit Prescription Access Litigation, which assisted the union in bringing its suit.

Drugmakers must do more to encourage side-effect reporting under a new industry code of practice published by the Association of British Pharmaceutical Industry. As of November, new promotional info must explicitly and “prominently” state that “adverse events should be reported” and provide details of the website to contact with concerns.

What else? Drugmakers will have to make publicly available a short description of financial and significant indirect support of patient groups; and sponsorship declarations must accurately reflect the nature of the company’s involvement.

Pharma must have a contract for health professionals and others employed as consultants, and are “strongly encouraged” to require consultants to declare this as an interest. And drugmakers are “encouraged” to publicly disclose available info about donations and grants to institutions supporting healthcare and research.

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Drugmakers will soon be able to use data from foreign clinical trials in new drug applications even if trials only compare new products to placebos instead of best available treatments. The change departs from the 1989 Declaration of Helsinki protecting human subjects in clinical research, the FDA’s previous standard, according to Integrity in Science Watch.

The new rule’s substitute standard says foreign trials should follow good clinical practices and include a review and approval by an independent ethics committee. A major difference between the Helsinki Declaration and GCP is the former’s insistence on using existing treatments instead of placebos if they are available, ISW writes, adding that the Helsinki Declaration had the effect of extending existing treatments to people in poor countries if they participated in clinical trials.

The change, which goes into effect in Octoer, is likely to push more clinical trials abroad, where an estimated 35 percent of all trials submitted to the FDA in new drug applications now take place, according to ISW. Unlike trials conducted in the US, drugmakers don’t have to submit an investigational new drug application (IND) to the FDA before beginning research in foreign countries.

The FDA estimates about 575 of the foreign trials submitted agency each year as part of an NDA don’t go through the IND process. The FDA rejected the notion that adopting the self-regulating GCP standard and eliminating references to the Helsinki Declaration “will hurt subjects in developing countries or result in less protection for subjects in foreign studies.” GCP requires trial sponsors closely monitor trial behavior and report adverse events, the agency noted.

Access to some HIV drugs is increasing in Thailand because of the country’s decision to issue compulsory licenses for certain meds, according to Winai Sawasdiworn, deputy secretary-general of the National Health Security Office, The Bangkok Post reports.

You may recall that, early last year, the Thai government issued a compulsory license to make a lower-cost version of Abbott’s Kaletra AIDS drug. The drugmaker later offered to sell an updated version called Aluvia at a reduced price, but only if Thailand agreed not to allow generics to be sold. But talks failed and Thailand last fall allowed India’s Matrix Laboratories to begin sales.

According to Winai, the first batch of generic Kaletra was delivered to state hospitals three month ago, and a shipment of generic Efavirenz, a Merck HIV drug for which a compulsory license was also issued, has been imported from India as well, according to the Post. His remarks were made in response to criticism from HIV advocates who charge Thailand has been slow to distribute the drugs.

This time, it’s in Europe. Switzerland’s Schweizerhall expects to market a lower-priced version of the widely used blood thinner within the month, and the news sent Sanofi-Aventis shares plummeting.

“The German authorities have basically finished the registration procedure and we’re now just waiting for the paperwork,” Luzi Andreas von Bidder, Schweizerhall’s chairman, tells Bloomberg News. The drugmaker is working with a “major generics company” and expects to start selling the product, called clopidogrel, this quarter. Sandoz and Ratiopharm will also market a generic Plavix, Dow Jones reports.

This is like a deja vu for Sanofi. You may recall that just two years ago, a generic Plavix was briefly sold by Canada’s Apotex, slashing some $1.75 billion in sales off the top line at Bristol-Myers Squibb, which jointly markets the drug with Sanofi in the US. Sanofi, which says the Plavix patent expires in 2013, is evaluating its legal options, but investors are concerned.

“We did not think at all Plavix hegemony would have been disputed before 2013,” Richelieu Finance analyst Alexandre Iatrides tells Bloomberg. “There are fears for Plavix competition all over Europe. In that case, it could cost 10 percent of Sanofi’s net income.”

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Vytorin may be grabbing all the headlines, but the controversial cholesterol pill isn’t gaining as much attention among docs. Over the past several weeks, Abbott’s Simcor, a new drug that combines Niaspan and generic Zocor, has gained the highest share of detailing among primary care physicians and cardiologists, according to ImpactRx data cited by Wachovia Capital Markets analyst Larry Biegelsen in an investor note this morning.

Simcor was approved in mid-February, but wasn’t launched until the end of March, so the data reflects the first month in which Abbott began promoting its pill. As Biegelsen notes, the cumulative total scrips for Simcor are equal to 30 percent of the cumulative Vytorin scrips during April. The data also show Niaspan has captured about 10 percent of newly written cholesterol scrips among PCPs, but slightly less among cardiologists.

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Lawmakers yesterday introduced legislation designed to speed the development of new, safer therapies for brain and nervous system disorders and injuries, which affect an estimated 100 million Americans and costs an estimated $1.3 trillion annually to treat, Scientific American reports.

The National Neurotechnology Initiative Act (NNTI), which has bipartisan support, calls for $200 million in federal funds to be set aside annually to research potential treatments and to establish an info clearinghouse from federal agencies to help coordinate efforts, the mag writes. The lawmakers charge a lack of coordination has impeded development of treatments for brain-related illnesses.

The funds would also go toward coordinating the work of 16 NIH branches that study brain-related injuries as well as to add and train employees at the FDA, which has been accused of dragging its feet on drug approvals because it is, among other things, understaffed, the mag adds.

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The FDA and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards, marking the first FDA effort to issue regulations instead of guidances for clinical trials, FDANews reports.

Existing FDA regs don’t take into account all the different types of organizations - vendors, co-investigators, site management organizations and contract research organizations - involved in conducting clinical trials, David Lepay, the agency’s senior advisor for clinical science, told the Association of Clinical Research Professionals annual conference, FDANews writes.

What are some of the problems? Let’s start with the fact that FDA regs fail to account for electronic data issues, data standardization, electronic health records, electronic patient-reported outcomes and electronic case report forms. “We are working with groups within and outside the FDA to address this,” Lepay said.

The FDA also is working to improve its internal processes to address “why it takes so long to disqualify clinical investigators” caught in wrongdoing, Lepay added. In March, two Republican congressmen asked the Government Accountability Office to examine why the agency has been so slow to discipline investigators (back story).

Nice to see you again. We hope your week has gone well. As usual, we have been quite busy and look forward to a respite this weekend. Still, there is much to be done. So please join us as we grab our daily cup of stimulation and catch up with events. Hope your day goes well…

Bristol-Myers CEO Buys 100,000 Shares (Yahoo/Reuters)

Takeda Expects Profits To Fall On Takeover Costs (Bloomberg News)

German Drugmaker Hikes Thalidomide Compensation (Deutsche Welle)

Celgene Poised For International Growth (The Star-Ledger of New Jersey)