This website does readability filtering of other pages. All styles, scripts, forms and ads are stripped. If you want your website excluded or have other feedback, use this form.
IPCI: FDA Approves First Focalin XR ANDA; Positive Incremental Step Toward Approval and October Launch for IPCI
20155 captures 20 Oct 2013 - 16 Nov 2018
About this capture
Organization: Internet Archive
These crawls are part of an effort to archive pages as they are created and archive the pages that they refer to. That way, as the pages that are referenced are changed or taken from the web, a link to the version that was live when the page was written will be preserved.
Then the Internet Archive hopes that references to these archived pages will be put in place of a link that would be otherwise be broken, or a companion link to allow people to see what was originally intended by a page's authors.
The goal is to fix all broken links on the web. Crawls of supported "No More 404" sites.
Collection: Wikipedia Near Real Time (from IRC)
This is a collection of web page captures from links added to, or changed on, Wikipedia pages. The idea is to bring a reliability to Wikipedia outlinks so that if the pages referenced by Wikipedia articles are changed, or go away, a reader can permanently find what was originally referred to.
On 8/15/12, Mylan (MYL, $23.40, Not Rated) received conditional ANDA approval for the 30mg dose of Focalin XR. This marks the first ANDA approval of a generic Focalin XR product and, in our view, may suggest ANDA approvals for the more commercially important 5mg, 10mg, 15mg and 20mg doses is likely in the near term. These four lower doses collectively account for 90% of Focalin XR scripts and are the basis of IPCI’s settlement to launch generics of all four doses as early as October 2012. As a reminder, the 30mg and 40mg doses of Focalin XR were introduced after the initial ANDA filings for the lower doses and were subject to a separate ANDA review process. IPCI is first to file on at least one of the low doses (5mg, 10mg, 15mg or 20mg doses) and has reached a settlement agreement providing for co-exclusive launch along with Teva Pharmaceutical (TEVA, $40.64, Not Rated) in early October 2012, pending FDA clearance. The 30mg dose is subject to a separate settlement agreement and a generic is unlikely to reach the market before 3Q13. There are currently no ANDA approvals for the 5mg, 10mg, 15mg or 20mg doses of Focalin XR. We’d note that the unique double-peak pharmacokinetics of all Focalin XR doses creates a greater level of regulatory complexity than most immediate release products. That FDA was comfortable with MYL’s characterization for the 30mg dose suggests the agency has developed a roadmap for evaluating the double peak, in our view. We view this as an important de-risking event for all pending Focalin XR ANDAs and are optimistic IPCI will win regulatory clearance in the near term. Reiterate Buy rating and $7.00 PT for IPCI based on the expected launch of Focalin XR.
What’s New? MYL received FDA clearance for its ANDA of the 30mg dose for Focalin XR. This is the first ANDA approval for any dose of Focalin XR and, in our view, is a meaningful de-risking event for all pending ANDAs of Focalin XR. IPCI is first to file on at least one of the low doses (5mg, 10mg, 15mg or 20mg doses) and has reached a settlement agreement providing for co-exclusive launch along with TEVA in early October 2012, pending FDA clearance. Following the MYL approval, we believe FDA clearance of IPCI’s ANDA for the low doses of Focalin XR is now more likely in the near term.
Attractive Focalin XR Economics to IPCI – Potential to Reach Breakeven: The 5mg, 10,mg, 15mg and 20mg doses of Focalin XR had combined 2010 branded sales of $465M. IPCI has partnered with Par Pharmaceutical (PRX, $49.85, Not Rated) for the launch of Focalin XR. Our forecast calls for Par and IPCI to recognize gross sales of $35M-40M over the initial six months with 75% gross margins and a long term gross margin of 45% once additional competitors enter the market. Our model assumes IPCI recognizing 30% of gross profit as revenue. Based on this forecast we believe the launch of Focalin XR may allow IPCI to approach cash flow breakeven and provide a solid base for future profitability based on approval of additional ANDA filings for sustained release generics.
PitchEngine™ is not responsible or liable for the accuracy, validity or quality of this content. Users are solely responsible for the facts and accuracy of all information posted and shared on the Site. PitchEngine reserves the right to reject or hold social media releases that it deems not newsworthy in its judgment, at any time.
Limitation of Liability - In no event will PitchEngine be liable for any direct, indirect, incidental, special, exemplary or consequential damages (Including, but not limited to, damages for loss of business profits, business interruption, loss of programs or information, and the like). This disclaimer of liability applies to any damages or injury under any cause of action, including, without limitation, those caused by any failure of performance, error, omission, interruption, deletion, defect, delay in operation or transmission, computer virus or bug, communication line failure, theft, destruction or alteration of or unauthorized access to the Site or materials on the Site.