Friday, October 09, 2009

DotW: Noble Pursuits

It's Nobel week and the rewards and riches went to experts who've spent their careers ferreting out the secrets of telomeres (medicine), ribosomes (chemistry), and fiber optics (physics). And then there was Barack Obama, who took home the much vaunted--and in this case highly controversial Nobel for Peace. Who needs Chicago when you have the Swedes and Norwegians, eh?

When their blackberries started buzzing, Obama aides reportedly thought they'd been punk'd--it's not April 1, for the record. It ain't hard to see why. Obama is only the third sitting president to win the award and he hasn't been in office long enough to resolve the Middle East conflict, the war in Afghanistan, or the ongoing conflicts in Iraq. What's more, those rumors keep swirling about an invasion of Canada...OK, we're kidding, but it's hard to parse the logic behind the award. Perhaps they meant to give him the Peas Prize in honor of Michelle's bounteous organic White House garden.

Whatever the reasons, we wonder if the political capital of the Nobel will give Obama the domestic leverage to push through meaningful health care reform. Another noble pursuit, the public option, which was given up for dead after weeks of debate, showed new signs of life this week. In an effort to get to 60 (it sounds like some self-help title aimed at lowering cholesterol and increasing dietary fiber, doesn't it?), Senate Dems have unveiled a compromise. (And this doesn't include the trigger option Senator Snowe is mulling.)

The plan is simple: establish a strong national public option for insurance coverage but give individual states the right to opt out. Such a solution, in theory, assuages the more liberal members of Congress afraid of losing their, ahem, moral compass, while pacifying the more conservative denizens. How this proposal would actually be implemented is a mystery. (Hey, this is a free publication. You want real solutions, go read The RPM Report or "The Pink Sheet".)
But enough dithering. It's time to check our moral compass--wait, it's here somewhere. Hark, the arrow is pointing straight toward...

Novartis/Paratek: A clearer, if not necessarily easier, pathway to FDA approval for antibiotics may have spurred Novartis' Oct. 8 purchase of exclusive worldwide rights to Paratek Pharmaceuticals' Phase III broad-spectrum antibiotic PTK 0796. Specific financial terms of the deal weren't disclosed, but Paratek said it could earn up to $485 million during the life of the deal, including an upfront payment and potential milestones. The privately-held Boston biotech also would receive undisclosed royalties on sales if PTK 0796 reaches the market.

The companies tout the compound as a first-in-class aminomethylcycline--basically a next-generation tetracycline--with the potential to become the first broad-spectrum antibiotic given once daily by I.V. or as an oral tablet to treat infections caused by drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) or multi-drug resistant Streptococcus pneumoniae. Currently being tested in a Phase III trial in complicated skin and skin structure infections (cSSSI), '0796 has demonstrated ability to work as a single agent against a number of infectious diseases. A second Phase III trial in community-acquired bacterial pneumonia (CABP) is planned, Paratek CEO Thomas Bigger told "The Pink Sheet" DAILY. Paratek will continue to participate in clinical study and manufacturing, while Novartis will take care of worldwide marketing.--Joseph Haas

Genentech/SurModics: Genentech inked a small deal--$3.5 million upfront and $200 million in donwstream milestones--with drug delivery specialist SurModics to develop a sustained release version of Lucentis this week. But don't let the small upfront fool you. Age-related macular degeneration remains a hot area of investment for VCs and biotechs in part due to the success of Lucentis. In 2008 it totaled $875 million in U.S. sales, and with the recent CMS decision it's unlikely Avastin will steal its market share anytime soon.

Despite Lucentis's effectiveness--it stops loss of vision in more than 90% of patients and restores some sight to about a third of that population--it's far from a perfect drug. The regular monthly injections are a burden to patients and physicians and costly to the healthcare system. New options to reduce the injection frequency would be a welcome step forward. News of the partnership sent SurModics' stock soaring nearly 20%, but there's plenty of competition to worry about. A number of companies are developing competing delivery or device solutions, including Neurotech Pharmaceutical, Buckeye Ocular, NeoVista, and Oraya Therapeutics.--Ellen Foster Licking

Arigene/Trimeris: South Korean medical equipment maker Arigene's acquisition of Trimeris marks the official end of a once high-flying biotech. Trimeris discovered the HIV fusion-inhibitor class of drugs and partnered its Fuzeon treatment with Roche back in 1999 for $10 million upfront. (The Swiss pharma has since paid out milestones totalling at least $24.75 million during the life of the deal.) But the two firms abandoned development of a follow-on fusion inhibitor, T-1249, in 2004, and a next-generation compound that offered the possibility of less-frequent dosing and a better safety profile didn't pan out either. Roche returned all rights to that program to Trimeris in 2007 in exchange for a nominal royalty on future sales.It's been tough going ever since. Enter Arigene, a South Korean firm that markets a line of medical instruments under the Ubiquitous Healthcare Systems label. Arigene is offering $3.60 a share in cash, a 40% percent bump over Trimeris's closing stock price on Oct. 1, to expand its operations into "the broader biotechnology industry."

GSK/Jiangsu Walvax Biotech: In its second vaccine-related collaboration with a Chinese company this year, GlaxoSmithKline announced Oct. 6 it's creating a joint venture with Jiangsu Walvax Biotech to develop and manufacture pediatric vaccines in China. The firms will build a new manufacturing facility for Priorix, Glaxo's three-in-one pediatric vaccine for mumps, measles and rubella, and they will develop vaccines beyond MMR. The deal also involves a technology transfer to let the JV make the vaccines locally, according to Glaxo. (FYI, Walvax is a recently created affiliate of China's second largest producer of the haemophilus influenzae type b (Hib) conjugate vaccine, Yunnan Walvax Biotech.) The two companies will invest a total of £41.2 million ($65.6 million) in the joint venture, with Glaxo initially providing more than half the money and owning a 65% stake in the JV. This is the second vaccine-related JV Glaxo has signed in recent months. In June, the Big Pharma inked a five-year deal with China's Shenzhen Neptunus to make seasonal, pre-pandemic and pandemic flu vaccines.--Joseph Haas

Our final deal of the week is actually a...

Ipsen/Spirogen: Partners since 2003 on a cancer compound, Ipsen this week gave worldwide rights back to Spirogen, which now takes the reins on future development and commercialization with help from a new financial backer. In the original deal, Ipsen gained rights to SJG-136, a DNA minor groove binder, and took a 20% stake in Spirogen. Six years later with the compound entering Phase 2 to test against ovarian cancer and blood-borne malignancies, Spirogen takes over, and Ipsen becomes eligible for commercial milestones and royalties. Spirogen will also tap private-equity firm Celtic Therapeutics Holdings, which invests in projects instead of companies, for up to $15 million to help development of the compound, now renamed SG-2000. "Up to..." can mean lots of things, of course, but the firms didn't say how much of it was guaranteed.--Alex Lash

(Image courtesy of flickrer niznoz used with permission through a creative commons license.)

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