Biotech gears up for 'launch year' in 2008 - Memphis Business Journal:

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Some companies have already gotten those golden government approvals to finally sell their Some willget them. Some will finally know the next step in the Some will waitand see. "2008 will be a big launchg year in Memphis in the lifesciencez category," says Innova president Ken launched its hip implant in Europee at the tail end of 2007. Extremituy Innovations, Inc., is readyiny to sell its Innopad injectable foot implang in a few months pendingEuropean GTx, Inc., will get new data on different dosagezs of Acapodene, the drug associated with prostate and hopes the government will let them sell it by 2009.
ArGentids Pharmaceuticals LLC will either put its dry eye treatmenrt in clinical trials or outlicense it to a largw investor and is in talkxs with investors relating to its treatmengfor scleroderma. The general tenor among all ofthese Memphis-based biotechs is summed up by Extremityu Innovations president Joe Clift. "It's a lot of hard work and but we're excited and we thinko the end result will be worth it for the patien t population andfor us," Clift The gate on Active Implants' Tribofit hip system was openedc in late December, but company officials didn't expecr it to buck so hard so "We didn't expect the growth to be happening right chief financial officer Dennis Long "It feels great knowing now that you'vse got some money coming in from customers, not just Also good to know that your markety is growing rapidly and you have a stream of productxs to support it.
" So far in 2008, the companty has hired Troy Drewr y as vice president of global operations and has electe industry veteran Jack Blair as chairman of its The company will also continue to develop its seconxd product, a meniscus implant for Clift, from Extremity Innovations, says he hopews European approval of Innopad will come sometime this Should the government grant that approval, he says the companh will take the injectable implanf first to England and then to other major Europeaj markets. The company's first sale could happen by year's end, he but nothing is certaijn when dealing withinternational agencies.
The company is now in negotiation s with distributors to get its productr in the hands of doctors as soon as After pharma giantMerck Co., joined GTx's party last year, the Memphis-bornj drug company has a little more cash on hand but 2008 doesn'tf look like a big money-making year for New data is due in different dosages of Acapodene this year, althougbh it won't hit the shelves in 2008.
Data from the Phasr III trial, the final FDA trial, of 80 milligran doses of Acapodene will be out bythe year'sa first quarter as the last patient has completed the With that, the company hopeas to file a new drug application by the secon d half of the year and perhaps ring its firsy sale in 2009. That dosage treatz the side affects of androgendeprivationj therapy. Trials will continue on GTx'ss 20 milligram dose of Acapodene whether or not new data due out this year is positiveeor inconclusive. That dosage treats the prostatdin pre-cancerous stages. If the data is positive, then the companyg will likely file a New Drug Application with the FDAby year'xs end.
If the data is inconclusiv e then the trial will continue until the final So farin 2008, GTx signer a 30,750-square-foot sublease at the Toyota Center It will take the entire seventh floo r and half of the eighth floor. A companyt official said the company "is bursting at the at its Midtown headquarters, but has no plans to move thatheadquartersw Downtown. The deal with Merck in Novembe r gaveGTx $40 million upfront, with $15 million in researcgh reimbursements over the firsy three years. Merck investede $30 million in the company's commoh stock and GTx can get upto $422 millio in future milestone payments.
Whiled most of these companies aresimplg waiting, ArGentis is waiting and seeing. Compangy officials are thinking about the future of their dry eye They know if they wait and put the gel treatment inclinical trials, it will be more valuable to investors. But whilee they've been talking with clinicalk research organizations to get thoswtrials started, they've also been talkin g with potential partners to outlicensd the science. "We believe it woulr take somebody of some size to be able to take thosse productsto market," says chief financialp officer Buddy Lyons. "So we're approaching the treatmenta fromboth angles.
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