Anchen Pharmaceuticals, Inc. Its Past and Its Future
Anchen Pharmaceuticals, Inc. Its Past and Its Future
Anchen Pharmaceuticals, Inc. Its Past and Its Future
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<strong>Anchen</strong> <strong>Pharmaceuticals</strong>, <strong>Inc</strong>.<br />
<strong>Its</strong> <strong>Past</strong> <strong>and</strong> <strong>Its</strong> <strong>Future</strong><br />
Chih-Ming Chen<br />
November 17, 2007<br />
1
History<br />
• Oct. 2002:<br />
–Founded in Irvine CA with the Goal of<br />
Developing Generic Controlled-Release<br />
Products (rented rooms in Stason)<br />
• Mar. 2004:<br />
–Built its Own R&D Facility <strong>and</strong> Pilot Plant<br />
in Irvine California (26,000 SF)<br />
2
Growth in Taiwan<br />
• Sept. 2003 to now:<br />
–Worked Closely with Empax Pharma<br />
( 英 伯 士 ) in Neihu, , Taiwan<br />
–Followed by Acquisition of Empax<br />
–Purchased ex Parke Davis Plant in<br />
Chung-Li Industrial Zone<br />
–70 plus Employees<br />
3
Milestones in Taiwan<br />
• 2006/2007:<br />
–3 ANDA’s Filed in US from C-LC<br />
L plant<br />
• July 2007:<br />
–Pre-Approval Inspection (PAI)<br />
–Zero 483 observations by US FDA<br />
• 2007/2008:<br />
–Preparing Production for Exporting<br />
Generic Drug Products to US<br />
4
Growth in Irvine CA<br />
• March 2006:<br />
–Built New Production Facility at Irvine, CA<br />
(45,000 SF) for Commercialization of <strong>Its</strong><br />
First Product, Bupropion ER Tablets<br />
–130 plus Employees<br />
5
Milestones in Irvine CA<br />
• Sept. 2004:<br />
–First ANDA (generic Wellbutrin XL) Filed as<br />
First-to<br />
to-File (FTF) with Paragraph IV<br />
Certification <strong>and</strong> Triggered Law Suit by GSK<br />
• Aug. 2006:<br />
–Won Law Suit <strong>and</strong> Granted 180-day Market<br />
Exclusivity<br />
6
Milestones in Irvine CA<br />
• Dec. 2006:<br />
–Received FDA Final Approval (after Citizen<br />
Petition was resolved)<br />
–Transferred Market Exclusivity of 300 mg<br />
Dose to Teva (manufactured by Impax)<br />
• March 2007:<br />
–Settlement on 150 mg Strength (5 parties)<br />
• June 2007:<br />
–Launched<br />
<strong>Anchen</strong>’s 300 mg strength in<br />
June 2007 (on 181 th day)<br />
7
Milestones in Irvine CA<br />
• Jan. 2006<br />
– Filed Another FTF with Paragraph IV<br />
Certification, Generic Ambien CR 12.5 mg<br />
– Citizen Petition by Sanofi<br />
• 1Q 2009:<br />
– Expect to Launch Generic Version of Ambien<br />
CR Tablets<br />
8
<strong>Anchen</strong>’s <strong>Future</strong><br />
• Annual Revenue Approx. $75M, <strong>and</strong> Growing<br />
• Expansions of Production Facilities in<br />
Chung-Li, Taiwan <strong>and</strong> Irvine, CA<br />
• Investment in R&D for Both Generic <strong>and</strong><br />
Br<strong>and</strong> Products<br />
9
<strong>Anchen</strong>’s <strong>Future</strong><br />
PRODUCT !<br />
PRODUCT !<br />
PRODUCT !<br />
10
<strong>Anchen</strong>’s <strong>Future</strong><br />
• Br<strong>and</strong> Products:<br />
–IP Protection<br />
–Sustainable/Growing Revenues<br />
•NDA Submissions<br />
–OCE (Old Chemical Entities)<br />
–NCE (New Chemical Entities)<br />
–Biotech Products<br />
11
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