Cyprus

The EU is now approaching 40 notified bodies under the Medical Device Regulation. The latest listing is the first in Cyprus.

More should be done to incentivize comparative clinical trials so as to allow better decisions on drug pricing to be taken, said Austria’s representative at a recent meeting of EU health ministers.

The number of European countries whose drug manufacturing site inspections the US regulator can rely on in place of its own inspections has grown.

The Valletta group of southern EU states on improving access to medicines continues to expand and now includes Croatia.

Karyopharm Therapeutics registered an $80m initial public offering within months of raising $67.2m in a Series B venture funding round and after the company said the private financing would allow it to complete two Phase II/III clinical trials for lead drug candidate Selinexor (KPT-330) and file for US FDA approval without having to engage a US partner.

In times past, biotechnology companies were relatively naïve on the terms of a deal to license their product to pharmaceutical companies. A good pharma trick used to be to allow the biotech partner to opt-in on the joint development of the licensed product so that lower upfront milestone payments could be traded for a bigger slice of the downstream commercialization pie. Unfortunately as companies like GenMab and Celltech later found (scripintelligence.com, 2 July 2010 and 19 November 2003), this development commitment rapidly became a millstone around their necks and led to renegotiated terms which favored the pharmaceutical company.

Paladin Labs, the Canadian speciality pharmaceutical company, is expanding its reach into the sub-Saharan pharmaceuticals market by acquiring all the Pharmaplan shares it does not already hold and then merging the business with the pharma assets of Litha Healthcare, to become its largest shareholder with a 44.5% stake. The series of transactions will cost Paladin some Can$52 million.

A disgruntled major shareholder has launched a $4.00 per share takeover bid for Cypress Bioscience, the US company best known for its fibromyalgia treatment Savella (milnacipran HCl).

The Russian pharmaceutical manufacturer, wholesaler and retailer Protek is launching an international offering of ordinary shares to institutional investors outside the US and Russia, which is expected to raise up to $400 million.

Alapis, a rapidly developing Greek company that operates in human and animal pharmaceuticals, has acquired 100% of the shares of Pharmacare, a distributor of veterinary products, for €950,000. Pharmacare, which was established in 1988 in Nicosia, Cyprus, distributes veterinary products on the local market for a number of companies includingBayer, Lohmann Animal Health, Boehringer Ingelheimand Danisco. It reported sales of €1.8 million and earnings before interest, taxes, depreciation and amortisation of €434,000 last year. Pharmacare will incorporate all of Alapis’s operations in Cyprus, currently carried out by Alapis Pharma, its local subsidiary.