I've still got shares that will break even at 27.50, nothing like buying at the top. I thought for sure we would win that patent lawsuit. Fortunately I have a lot more that broke even at 4.80.
Not sure if it was Merck, but I remember them patenting a new method to manufacture that would bypass the infringement by not using e-coli.
From 10-Q filed 8/8/2008 On March 5, 2007, we reached a settlement agreement ending all litigation with Tercica, Inc. and Genentech, Inc. Pursuant to the agreement, we agreed to cease sales and marketing of IPLEX for the treatment of short stature disorders in the United States and agreed to withdraw our European Marketing Authorization Application for IPLEX for treatment of short stature disorders. We continue to provide IPLEX to named patients with ALS in Italy under our Expanded Access Program. We pay a royalty under our settlement agreement for all cost-recovery
that we receive under the Expanded Access Program. The settlement agreement also gives us the right, through a worldwide development partnership with Tercica and Genentech, to market IPLEX for conditions not related to short stature. These indications include severe insulin resistance, MMD and HARS, among others. The development partnership includes provisions that give us a 50% share of profits and reimbursement for 50% of development costs if either Tercica or Genentech exercises opt-in rights for marketing of IPLEX in any of these new indications that we develop.
I think in the agreement that they would not pursue marketing in Europe. We did license iplex for Retinopathy to premacure ab / Shire. They are still doing trials but the end date for the phase 2 trial is in 2021. Search for SHP-607-201 for more info.
I think we may have licensed iplex to Premacure ab (part of Shi re I think.) for Retinopathy. They may be able to manufacture it. And I believe they are still doing trials. Search for SHP-607-201 or ROP-2008-01
Do a search for this. This should also make you happy. ROPP-2008-01
Start over meant to start the batch over...Merck bought the factory to pursue making biologics such as biosimalars not to make iplex. That sale is what gave us the money to buy Arikace.
From 10k 3/31/2009 We have previously manufactured our own supply of IPLEX™ and rhIGFBP-3 at the Boulder, Colorado, FDA-approved manufacturing facility. The manufacturing process requires compliance with current good manufacturing practices, or cGMP, and other similar regulations. IPLEX™, a complex of two proteins, rhIGF-1 and its binding protein rhIGFBP-3, are manufactured using recombinant DNA technology. This manufacturing process is complicated and involves expression of the proteins by bacterial fermentation followed by purification and combination. We currently outsource to third-party contract manufacturers some of the analytical testing and the final fill, finish and labeling of IPLEX™. The transfer of the Boulder facility to Merck will take away our internal IPLEX™ production capability. We believe, however, that we will have sufficient inventory of IPLEX™ at the time of the sale to support our ongoing ALS EAP in Italy through 2010 together with the IPLEX™ requirement for the clinical trial currently being planned with the FDA for ALS patients in the US. Any requirements for IPLEX™ beyond 2010 or any significant increase in demand beyond our current commitments either in the MMD or ALS fields will require that we identify a Contract Manufacturing Organization (“CMO”) to produce the necessary IPLEX™ to meet the demand. It is estimated that the tech transfer of our IPLEX™ production process could take 12 to 18 months once a CMO has been identified
I know they had problems making increlex and had to throw away bad batches, and iplex is a similar product that was also made similary. (patent infringement). And that we spent a lot of money on the factory to make it, which has since been sold. (I think for around 130 million in 2009 to Merck). Biologics can be very difficult to reproduce, one little problem and you may have to start over.
I understand it is very difficult and expensive to manufacture.