Merck & Co. presents positive Phase IIb data for CETP inhibitor

Data from a Phase IIb study showed that Merck & Co.'s cholesteryl ester transfer protein (CETP) inhibitor, anacetrapib (MK-0859), raised levels of HDL cholesterol in patients with dyslipidemia by as much as 139 percent and did not increase their blood pressure, compared with placebo. Analysts estimate that a marketed HDL-raising drug could have peak annual sales of more than $15 billion.
As part of the study, 589 patients with dyslipidemia were randomised to receive placebo, or one of four doses of anacetrapib alone or in combination with Pfizer's Lipitor. After eight weeks, patients who received anacetrapib monotherapy had increases in HDL cholesterol ranging from 44 percent to 139 percent, compared with an increase of 4 percent for those in the placebo group. The results showed that patients in the anacetrapib monotherapy group experienced decreases in LDL cholesterol ranging from 16 percent to 40 percent, compared with 2 percent in the control group.
Additionally, Merck noted that the combination of anacetrapib plus Lipitor resulted in "significant incremental reductions in LDL-C and increases in HDL-C compared to atorvastatin alone." Dan Bloomfield, a senior director with Merck Research Laboratories, commented that "having a compound like ours, that doesn't raise blood pressure, may give us an opportunity to test the mechanism of a compound that doesn't have off-target toxicity." Bloomfield added that "the ultimate benefits of CETP inhibition on clinical outcomes have not yet been established."
However, Merck indicated that it plans to evaluate data on Pfizer's experimental CETP inhibitor torcetrapib, which will be presented at an upcoming meeting, before deciding whether to proceed with further testing of anacetrapib. Pfizer halted clinical development of its compound in December after the treatment was linked to an increased risk of death.

Lupin to buy a Japanese Co.

The march of India’s top pharmaceutical companies around the globe has continued with Lupin Laboratories’ purchase of an 80% stake in Japan’s Kyowa Hakko, a manufacturer of generic medicines and active pharmaceutical ingredients (APIs).Lupin is one of a number of Indian pharmaceutical companies that have been trying to get into the Japanese market for generics, which is still fairly small despite Japan being the second-largest pharmaceutical market in the world. With the Japanese health system struggling to cope with a hefty drugs bill, the betting is that generics will grow quickly, with new legislation in 2006 allowing doctors to authorise the dispensing of a generic drug for the first time. The government has also introduced new regulations, to be implemented by 2011, designed to stimulate the local generic industry.In April this year Zydus Cadila bought Nippon Universal Pharmaceutical, while at the end of 2005 Ranbaxy Laboratories set up joint venture, Nihon Pharmaceuticals, with Nippon Chemiphar. Dr Reddy’s Laboratories said earlier this year it was eyeing Japan, but had not yet decided on its entry strategy.Lupin said that Kyowa ranks among the top 10 Japanese generic companies, with sales of 7.4 billion yen ($64 million) in the year ended March 2007, mainly from its cardiovascular, respiratory, anti-allergy and gastrointestinal product ranges. It intends to eventually acquire the remaining 20% of the Japanese company.'Significant' moveDr Desh Bandhu Gupta, Lupin’s chairman, said: “This is a very significant part of our strategy to tap leading global markets and establishes a beachhead in the second largest pharmaceutical market in the world.”At present generics account for just 5% of the Japanese drug market, according to figures supplied by the Japanese Generic Pharmaceutical Manufacturers Association, compared to around 25% in Germany and the UK and 8% in the USA. Lupin will be hoping that market share rises quickly in the coming years.

Massive Layoffs in Marketing/Sales Division at Novartis

Last Friday, Novartis announced that it would lay off 1,260 jobs, primarily in the sales and marketing sectors, in an effort to save $230 million a year.
Of the jobs being cut, 750 will be internal, while the rest will be third-party sales representatives. The company says it will put more emphasis on its nonprescription market and biological medicines.
The company has been hit with some specific problems in the last few years, particularly the delay of its type 2 diabetes med, Galvus (which received an approvable letter in February), and the withdrawal of Zelnorm, for safety concerns.
"Even if you factor those things in and step back, I don't see the situation being a whole lot different than any of its peers," said Mike Luby, CEO of marketing information service company TargetRx. "Novartis has been blessed with new product launches, but the situation is still the same—it has an enormous infrastructure, pressure for growth, competitiveness on almost every front, and it has to figure out how to crack the code on making its sales force more effective and more efficient."
Novartis is bringing in Joe Jimenez, a former board member for AstraZeneca, as the head of pharmaceuticals. Although his background is primarily in finance, some analysts feel he might be the right guy for the job.
"Maybe it's time for a fresh view of the same question. The industry needs to identify areas of opportunity from the perspective of being more efficient," said Barbara Ryan, analyst at Deutsche Bank. "Pharma is feeling the pressures of a slowing top line—a function of generic competition, low productivity from R&D, and pricing pressures globally. In an effort to improve its return, industry needs to find more efficient ways to operate, including lowering head counts and addressing all processes whether they be manufacturing or selling and marketing or R&D."

GSK signs deal worth USD 1 Bn for onco drug

GlaxoSmithKline and Synta entered into a global collaboration agreement to develop and commercialise Synta's oncology drug, STA-4783, which is entering Phase III development for metastatic melanoma. The US biotechnology company could receive more than $1 billion from the deal announced Wednesday.
As part of the agreement, GlaxoSmithKline will make an upfront payment of $80 million to Synta, which is also eligible to receive milestone payments of up to $885 million. The companies will jointly develop and market the treatment in the US, while GlaxoSmithKline will be responsible for the drug's development and commercialisation in the rest of the world. Synta will receive royalties on sales of the marketed product outside the US, under the terms of the deal. Additionally, GlaxoSmithKline has an option to purchase as much as $45 million in Synta stock.
The companies said that STA-4783 is a first-in-class small-molecule oxidative stress inducer, and Synta CEO Safi Bahcall remarked that "there hasn't been a drug that acts in a new mechanism that's been approved in 30 years for metastatic melanoma." Furthermore, GlaxoSmithKline's chairman of R&D, Moncef Slaoui, remarked that "the data we have seen from the Phase II trials conducted by Synta have given us confidence in the potential of STA-4783 as a novel means of treating metastatic melanoma." Slaoui added that the deal "further strengthens our late stage oncology pipeline, which currently includes ten Phase III programmes."
Commenting on the news, Collins Stewart's Navid Malik noted that "GlaxoSmithKline is keen on strengthening its oncology pipeline and this is a good way of doing it." The analyst called STA-4783 a "high-risk product," and suggested that if it succeeds in late-stage testing, it could "bring high rewards for both GlaxoSmithKline and Synta."
The Phase III trial of the drug is expected to enrol 600 patients.

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