Pharma Notes

Dalton Pharmaceutical Ser-

vices (Toronto, ON) has successfully completed its most recent Health Canada audit. The company has received a ‘Compliant’ rating following the regulator agency’s inspection of Dalton’s GMP manufacturing facility. The Establishment License issued by Health Canada will enable Dalton Pharma Services to continue to manufacture, test and ship sterile commercial products for its existing clients. In addition, Dalton’s solid dose manufacturing suites were also inspected and found to be compliant for formulation, granulation and encapsulation of drug products. In separate audits, Dalton Pharma Services was also found to be compliant with GMP API manufacturing, sterile filling and testing standards for pharmaceutical products in the European Union. “These successful inspections will allow us to continue to execute on our vision to accelerate drug development for our clients’ pharmaceutical products globally,” said Peter Pekos, president and CEO of Dalton Pharma. “Dalton’s ability to carry out commercial manufacture of sterile, solid dose pharmaceuticals and API provides integrated drug development and manufacturing solutions. Dalton’s reputation for its ability to complete complex drug manufacturing projects in GMP-compliant facilities enhances our clients’ success in bringing the medicines of the future to the market.”

Novozymes and ProMetic

Life Sciences Inc. (Mount-Royal, QC) have entered into an alliance regarding proprietary albumin purification technology based upon a synthetic-ligand affinity adsorbent developed by ProMetic’s UK subsidary, ProMetic Biosciences Ltd. The purification technology has been designed for the rapid and cost-effective development of Novozymes’ albufuse(R) albuminfusion molecules.Under the terms of the co-marketing alliance the companies will jointly promote the use of a new synthetic-ligand affinity adsorbent, marketed under the trade-name AlbuPure® , as a platform approach for the purification of albumin and albumin-fusion proteins. ProMetic will be the exclusive manufacturer and supplier of AlbuPure®, however both parties will retain ownership of their respective technologies and both Novozymes and ProMetic will have the right to market AlbuPure®.

The U.S. Food and Drug Administration (FDA) has advised YM BioSciences Inc. (Mississauga, ON) that it may begin enrolling patients at its U.S. clinical sites in two ongoing randomized double-blind Phase 2 trials of its lead product nimotuzumab. One of the two trials is in non-small-cell lung cancer (NSCLC) patients who are ineligible for curative treatment and being treated palliatively and the other in patients with brain metastases from NSCLC. Current NSCLC palliative treatment and treatment for brain metastases is radiation alone. YM BioSciences announced on August 10, 2009 that its wholly-owned subsidiary, YM BioSciences USA Inc. received a license from the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) that lifted the limitation on the development of nimotuzumab in the U.S. for patients with solid tumor cancers. The Phase II study that is examining the effects of nimotuzumab when added to palliative radiotherapy to treat intrathoracic disease from NSCLC, has a target enrollment of 128 patients and is being conducted internationally. Patients diagnosed with Stage IIb or III NSCLC ineligible for curative treatment, or Stage IV NSCLC patients with progressive disease within the chest, are eligible to enroll into this study. Palliative radiotherapy is effective for improvement of symptoms resulting from lung disease, improvement in quality of life in one third of the patients, and improvement of survival. Completed Phase I studies executed in Canada and Korea have demonstrated that nimotuzumab has the prospect of optimizing palliative care in this indication with initial stimulating results in this population. The primary objective of the trial is to evaluate the difference in Overall Survival between the arms with secondary endpoints being the differences in Time to Progression, Response Rate, Quality of Life, and Progression-Free Survival.

Isotechnika Pharma Inc. (Edmonton, AB) announces its wholly owned subsidiary, Isotechnika Labs, has amended its agreement with Paladin Labs Inc. (Montréal, QC) concerning its remaining stake in the revenue stream from the Isodiagnostika business sold to Paladin on June 18, 2009. Under the agreement, Isotechnika Labs was entitled to receive a revenue stream equivalent to 88 percent of the net profits of Isodiagnostika through to June 18, 2016. This amendment results in a one time up front payment of $1.65 million with an additional amount up to $350,000 payable by January 31, 2011, based on Isodiagnostika sales in 2010.

Thallion Pharmaceuticals Inc.

(Montréal, QC) and LFB Biotechnologies have signed a definitive development and commercialization agreement for Shigamabs®, Thallion’s product candidate for the treatment of Shiga toxin-producing E. coli, or STEC, infections. Thallion has granted LFB, an affiliate of the Laboratoire francais du Fractionnement et des Biotechnologies of Les Ulis, France, an exclusive license for the commercial rights to Shigamabs® in Europe, South America and other territories of strategic interest to LFB, including Russia, Turkey, China, South Korea and Northern African countries. Thallion retains commercial rights for the rest of world, including North America. The agreement follows the binding Letter of Intent signed in December 2009 between the two parties.

Spectral Diagnostics (Toronto, ON) has received investigational device exemption approval from the U.S. Food and Drug Administration (FDA) for Toraymyxin™. Spectral Diagnostics and BioMS Medical Corp. (Edmonton, AB) have also entered into a services agreement whereby BioMS will assist Spectral, as required, in its commercialization of Toraymyxin™, a therapeutic hemoperfusion device for the treatment of severe sepsis. This approval permits Spectral to initiate its planned pivotal trial for Toraymyxin™ in the U.S.