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It’s Getting Tougher Labopharm LabopharmGets Gets FDA FDA Okay Okay For For Once-Daily Tramadol (Ryzolt) --Finally Finally December December 31, 31, 2008: 2008: 12:03 12:03 PM PM ET ET To To say say Labopharm Labopharm Inc.'s Inc.'s (DDSS) (DDSS) first first U.S. U.S. drug drug approval approval followed followed a a long long and and winding winding road road Marketing would would be be an an partner understatement, understatement, Purdue but but Pharma the the tramadol tramadol plans saga saga to with with launch the the U.S. U.S. in FDA FDA Q2 is is 2009. finally finally over over and and investors investors aren't aren't dwelling dwelling on on the the past. past. Earlier Earlier Wednesday, Wednesday, the the Canadian Canadian specialty-pharma specialty-pharma company company announced announced that that the the FDA FDA approved approved "This its its is once-daily once-daily a great formulation formulation milestone of of for painkiller painkiller the company tramadol, tramadol, named named and Ryzolt. Ryzolt. fantastic Labopharm, Labopharm, news for which which has has been investors, been public public for for but 12 12 years, this years, approval went went through through has hoops hoops been to to get get a the long the drug drug time approved, approved, coming," having having said to to redo redo a trials, trials, construct construct new new statistical statistical analyses, analyses, and and even even engage engage the the U.S. U.S. regulator's regulator's formal formal disputedisputeresolutionresolution biotech process. process. observer familiar with the company. "I can't help but believe It It expects expects the opportunity marketing marketing partner partner today Purdue Purdue is much Pharma Pharma smaller to to launch launch than the the product it product was in in a the the few second second years quarter. quarter. ago. "This "This is is a a great great milestone milestone for for the the company company and and fantastic fantastic news news for for investors, investors, but but this this approval approval has has The been been results a a long long time time will coming," coming," be apparent said said a a biotech biotech enough observer observer once familiar familiar the company with with the the company. company. launches "I "I the can't can't drug." help help but but believe believe the the opportunity opportunity today today is is much much smaller smaller than than it it was was a a few few years years ago. ago. The The results results will will be be apparent apparent enough enough once once the the company company launches launches the the drug." drug." … In In the the U.S., U.S., Ryzolt Ryzolt will will face face competition competition from from Biovail Biovail Corp.'s Corp.'s Ultram Ultram ER, ER, which which has has a a three-year three-year head head start start and and is is backed backed by by marketing marketing juggernaut juggernaut Johnson Johnson & Johnson. Johnson. Despite Despite the the lead lead and and having having the the market market to to itself, itself, the the drug's drug's sales sales have have been been a a disappointment disappointment to to investors. Ryzolt investors. will In In 2007, face 2007, Biovail's Biovail's competition revenue revenue from from Ultram Ultram Biovail ER ER was Corp.'s was $86.7 $86.7 Ultram million; million; through through ER, which the the third third has quarter quarter of of 2008, 2008, revenue revenue was was $ $ 64.1 64.1 million. million. 14 To say Labopharm Inc.'s (DDSS) first U.S. drug approval followed a long and winding road would be an understatement…Ryzolt, a QD tramadol ER for moderately severe chronic pain, first received an approvable letter from the FDA in 2006 – not data related. Since then, Labopharm has filed a formal dispute resolution with the FDA. a three-year head start and is backed by marketing juggernaut Johnson & Johnson. CNNMoney.com © Defined Health, 2009 Pain Insight Briefing
The Risk : Reward Profile for Novel Pain Agents 15 Development Risk Regulatory Risk THE BAR © Defined Health, 2009 Pain Insight Briefing Market Risk
- Page 1 and 2: Game Changing Plays in the Pain Mar
- Page 3 and 4: Our Disclaimer 3 The information in
- Page 5 and 6: Everyone Hurts “Pain is whatever
- Page 7 and 8: It’s A Big Market with a Few Domi
- Page 9 and 10: $ Millions But Few “Big Pharma-Si
- Page 11 and 12: Pain Historically: Drug Delivery ha
- Page 13: It’s Getting Tougher Labopharm La
- Page 17 and 18: Current Standard of Care for Pain
- Page 19 and 20: Leaving Plenty of Unmet Need to Be
- Page 21 and 22: In the Meantime, Let’s Teach Old
- Page 23 and 24: A Better NSAID: NicOx • Naproxcin
- Page 25 and 26: A Better NSAID: NicOx 25 Company pr
- Page 27 and 28: A Better NSAID: Pozen / AstraZeneca
- Page 29 and 30: The First-to-Market Topical NSAIDs
- Page 31 and 32: Even So, Flector is Expected To Be
- Page 33 and 34: Now We Have a Patch and a Gel Volta
- Page 35 and 36: The Need is Clear 35 © Defined Hea
- Page 37 and 38: Progenics / Wyeth: Making Opioids M
- Page 39 and 40: Adolor / Pfizer: Making Opioids Mor
- Page 41 and 42: Like All Things CNS, It’s Not So
- Page 43 and 44: A New, and Better Opioid from J&J /
- Page 45 and 46: A New, and Better Opioid from J&J /
- Page 47 and 48: Opioid Abuse Deterrence 47 © Defin
- Page 49 and 50: King Pharmaceuticals: Making Big Be
- Page 51 and 52: But Also Significant Hurdles • Te
- Page 53 and 54: The Technologies are Not the Proble
- Page 55 and 56: The Real Issue is Risk Management
- Page 57 and 58: Fentanyl: Again, REMS is the Big Re
- Page 59 and 60: Lessons from Fentora 59 What the FD
- Page 61 and 62: For Some Mechanisms, the US Regulat
- Page 63 and 64: FAAH Pipeline 63 Compound SSR 10101
The Risk : Reward Profile for Novel Pain Agents<br />
15<br />
Development Risk<br />
Regulatory Risk<br />
THE BAR<br />
© Defined Health, 2009<br />
Pain Insight Briefing<br />
Market Risk
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