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Showing posts with label Malaria. Show all posts
Showing posts with label Malaria. Show all posts

Friday, April 09, 2010

Deals of the Week Pines for the Magic Number

Numbers are good. A couple of our favorites are 3 and 0, which happens to be the win-loss record of the San Francisco Giants after their opening series. We also like 59, the number of points Butler University scored against the Duke Blue Devils in Monday's NCAA championship game. Unfortunately Duke scored 61, prompting Butler fans the world over to ask head coach Brad Stevens -- who briefly had a marketing job at Eli Lilly before he joined Butler -- if he still had Prozac or Cymbalta samples to hand out. (If Stevens is fresh out, fans can just go to the Lilly Web site.)

We're thinking somberly of other numbers this morning: 34, the years John Paul Stevens will have served on the Supreme Court after his upcoming retirement, and 4, the number of miners still missing but possibly alive in West Virginia.

Our mind wanders to numbers in the wider world because here in the little sphere of biopharma deal-making, numbers were a wee bit hard to come by this week. Only one of our four chosen deals disclosed figures we could sink our teeth into, and even then it was all biobucks. Bah humbug!

Good thing, then, the deals this week were rich with more important things in life--unmet medical need for old scourges (malaria vaccine and tuberculosis) and cutting-edge science (stem-cell manipulation). We're all antsy to get our weekend started, so it's a-one, and a-two and...



Pfizer/MicuRx/Cumencor: With its April 6 deal with two biotechs to develop novel treatments for multi-drug resistant tuberculosis (MDR-TB), Pfizer not only addresses a critical unmet need in Asia but gains even more of a foothold in a key emerging market. Outside the developed world TB is an enormous problem, resulting in 5,000 deaths a day. China is a hotspot, with more than 25% of all cases of MDR-TB. The deal with US-China hybrid MicuRx and China-based Cumencor calls for Pfizer to provide an upfront payment, preclinical research funding, and downstream milestones linked to a drug’s development and commercialization. Specifics weren't disclosed, but even if the upfront money isn’t huge, it should push molecules well into the clinic since all the development work will be performed in Shanghai. For MicuRx, the agreement validates the biotech’s proprietary antibiotic discovery platform and is the firm's first deal since its $10 million Series A led by Morningside Group in 2007. For Pfizer, the deal highlights its interest in Asia-prevalent diseases, including head and neck cancer. In February, Pfizer signed a precompetitive deal with Lilly and Merck to form the not-for-profit the Asian Cancer Research Group. This week Pfizer highlighted its R&D efforts in Asia and its desire to increase the number of Asia-based clinical trials by 10%.--Ellen Foster Licking

Sanofi-Aventis/CureDM: Sanofi is in-licensing an early-stage compound with potential to restore a diabetic's ability to produce insulin and other pancreatic hormones, the company announced April 8. It is paying up to $335 million, plus sales royalties, to CureDM, a heretofore low-profile six-year-old startup, for global development and commercial rights to the novel human peptide, Pancreate. The firms did not break down the distribution of payments. The deal marks another move by Sanofi to bolster its diabetes business and eventually lessen its reliance on sales of its leading long-acting insulin Lantus and the short-acting insulin Apidra. It comes only a week after the Big Pharma bulked up the drug delivery portion of its leading diabetes franchise by entering into a deal with another small biotech, AgaMatrix, for blood glucose monitors.--Carlene Olsen

Fate Therapeutics/Verio Therapeutics: The San Diego stem-cell firm Fate bought a Canadian startup -- two scientists and their CEO, really -- for an undisclosed amount to bolster its efforts to develop drugs that push adult stem cells into therapeutic behavior. Fate has the small-molecule FT1050 in Phase 1 as a treatment to stimulate a cancer patient's hematopoietic stem cells to replenish after a cord blood transplant. Verio's scientists, based at a research hospital in Ottawa, are investigating protein-based drugs that encourage regeneration of cardiac, pancreatic and skeletal muscle tissues. The therapies could help repair damage due to heart attack, diabetes and muscular dystrophy. Verio CEO Frank Gleeson told "The Pink Sheet" DAILY that of Verio's preclinical compounds, the cardiac program has the clearest path to reaching the clinic. Verio has pulled in $1 million in seed funding; joining Fate lets it hire a few more scientists by year's end, Gleeson said. Fate in November closed a $30 million B round and execs say the cash should last for another year and a half, even with the Verio purchase. In addition to drug development, Fate aims to create a supply of induced pluripotent stem cells that it can license as discovery tools to drug firms.--A.L.

GlaxoSmithKline/Crucell: The two firms said Apr. 6 they would join forces on a next-generation malaria vaccine by combining two existing vaccines, but they'll need outside help to pay for it. Terms weren't disclosed, but the firms will each contribute a vaccine candidate and seek third-party funding for clinical trials. If a Phase I/IIa trial is successful, they will ask for financial help from public or non-profit partners to push into later-stage trials. The deal follows a 2003 agreement GSK and Crucell signed with the Walter Reed Army Institute of Research to test their then-preclinical vaccines both as standalone and combined candidates. Data suggested a combined approach would be more effective. Malaria is the fifth deadliest infectious disease in the world, and second deadliest in Africa. The agreement is the latest in a series of R&D tie-ups by the Dutch vaccine maker, which has benefited from going against industry trends and expanding its R&D footprint. --A.L.

Photo courtesy of flickr user fringley.

Wednesday, January 20, 2010

Glaxo's Witty Tries To Fix An Industry Problem


For the second time in a year, Andrew Witty has succeeded in getting in front of a contentious issue that plagues the pharmaceutical industry – finding ways to provide greater access to medicines to poor countries. Last year, the GlaxoSmithKline ceo trumpted plans to create a patent pool for tropical diseases; reinvest 20 percent of profits from meds sold in the Least Developed Countries, and reduce prices there by 75 percent.

The February 2009 effort (see the pronouncements here) won him kudos for addressing topics that his peers had mostly confronted in fits and starts. Generally pleased with the reaction, Witty this week embarked on what amounted to a 24-hour media blitz – including a widely telegraphed speech this morning before the Council on Foreign Relations in New York – to announce his next steps.

His latest moves read like a laundry list of NGO initiatives: creating an ‘open lab’ with $8 million in seed money and space at a Glaxo facility in Spain so that up to 60 scientists from erstwhile locales can research neglected tropical diseases. Glaxo is also contributing 13,500 compounds – including chemical structures and assay data – that will be available on web sites for developing new malaria treatments. There’s more: BIO Ventures for Global Health will run the ‘knowledge’ pool announced last year and collaborations were inked with the Emory Institute for Drug Discovery and South Africa’s iThemba Pharmaceuticals. Finally, in a related development, he promised to limit profits on a malaria vaccine, which is in Phase III testing, to 5 percent and contribute the proceeds to Glaxo’s R&D budget for vaccines to combat neglected tropical diseases (see more in The Pink Sheet).

“The speech I made this morning really tries to build on what I started a year ago,” Witty told a handful of bloggers (including yours truly) at the majestic New York Academy of Sciences offices in lower Manhattan following his morning speech. “We’re really trying to identify a more pluralistic approach to solve very difficult problems rather than constantly use the same approach…and be much more open-minded and be prepared to try new things.”

Certainly, Witty deserves some credit for taking these steps. For years, drug makers have been skewered for failing to do more to make their meds widely available in various countries. Over the past year, the Glaxo ceo has managed to alter many perceptions by conveying a willingness to listen and act. Compare that to the running battles between drug makers and governments that, sometimes, led to brinksmanship over compulsory licensing. Of course, those disputes were generally over very profitable treatments for heart disease, cancer or AIDS. By comparison, malaria treatments are the equivalent of low-hanging fruit, not best sellers that command top dollar in developed countries.

When questioned about the intellectual property and commercialization rights to the 13,500 compounds donated for malaria research, Witty was quite firm in saying that Glaxo wouldn’t benefit from any malaria treatment that may be discovered and developed, unless a company later approached his team for a deal of some sort. “But a cardiovascular medicine,” he added, “that’s a different consideration.”

And he tried hard not to appear defensive when asked about an idea being pushed by Medicines Sans Frontieres and Unitaid, the international drug-purchasing agency based in Geneva, to create a patent pool for HIV medications. Recent reports mention several drug makers that have held talks, but Glaxo wasn’t among those listed. By contrast, Glaxo’s interest in AIDS drugs did make headlines last year, but largely in connection with a joint venture formed with Pfizer, called ViiV. Nonetheless, Witty insisted that Glaxo is, in fact, willing to explore the possibility.

“We actually have eight voluntary licenses for a variety of HIV drugs and each one covers 44 countries…That’s a huge portfolio of openness. These are licensed to both African and Indian manufacturers and they are royalty-free. And we gave permission to generic companies to create combination products. As a result, last year they supplied more than four times the volume than what GSK supplied,” he argued. “So we’re already doing what you’d envision what the pool would generate.

“Where are we with the (Unitaid) pool? Not surprisingly, we’re very aligned with the goal. And we’re engaged in conversation to try to work with them, as are others, in ways that are practical. The ViiV team met (with them) just yesterday or the day before…The meetings are constructive and cordial, and we’re engaged in the spirit of trying to get details hammered out…But the decision lies with the management board of ViiV. As the biggest shareholder, we’re pretty close to knowing what’s going on there. But we’re very aligned with their goals…The devil is in the details and we need to get the details to work.”

Ironically, Witty acknowledged a wee bit of disappointment, but not much surprise, that other large drug makers have yet to embrace the patent pool for neglected tropical diseases he would like to develop. To date, only Alnylam Pharmaceuticals has agreed to join. In explaining the paucity of cooperation, Witty put on a brave face while also trying hard not to deliver a spanking:

“I do hope other companies will join,” he lamented. “…I can completely understand why they take their time. For those other companies, it came a little out of the blue. They’ve had to assess their response after the impact of (the announcement last year). There’s a fair degree of interest among some. But not to overstate, I think there are some (companies) that will never come into it…I hope they will join…But a year’s not a long time…Maybe it is in the blogosphere, but not in the pharmaceutical industry.”

Prodded by another question, Witty then conceded that his idea for a patent pool may one day expand to include prospects to treat other conditions beyond tropical diseases. For now, though, he pointed to the fact that there is little “market stimulation” for discovering meds to treat tropical diseases, unlike so many other illnesses. “But if it works, engages people and inspires people,” he said, “then, absolutely.”

Not everyone is enamored of his efforts, however. Health Action International, an advocacy group that pushes for greater access to medicines, says it’s still waiting for Witty to respond to questions posed last spring about Glaxo’s initiative to lower prices in countries in which this has taken hold. For his part, Witty yesterday preached patience.
“If we sit back as a group and constantly look to design the perfect model to fit the situation, to see what’s working, we’ll never do anything. So let’s see what opportunity we can create and move to the next problem,” he offered. “…This is a step on a journey and journeys have multiple steps.”