Three weeks ago, Nektar Therapeutics’ (San Carlos, California) executives said in a press release that they were highly “disappointed” when Pfizer reported plans (New York) to abandon Exubera, an inhaled insulin that both companies had partnered on to bring to the U.S. (Medical Device Daily, Oct. 22, 2007). Pfizer cited low sales as a reason for abandoning the drug, coupled with the patient-unfriendly device used for inhaling, almost as bulky as a tennis can.
But oh, what a difference time and a multi-million-dollar settlement can make.
Pfizer reported yesterday that it would pay Nektar $135 million to resolve all remaining contractual obligations between the companies. It was news that mended fences between the two companies.
In a joint statement, Jeffrey Kindler, CEO of Pfizer, and Howard Robin, president/CEO of Nektar, made favorable comments regarding the transaction.
“The agreement strengthens our relationship and demonstrates our ability to work together to craft a solution that allows Nektar the ability to pursue additional commercial opportunities for the Exubera and NGI inhaled insulin franchises. Further, we look forward to advancing our joint development of PEGylated human growth hormone therapy to treat short stature and growth problems,” the two executives said.
In addition to the fee the agreement also covered remaining obligations relating to Next Generation Inhaled Insulin (NGI), a product currently in Phase I clinical development.
In addition, in the event that a new partner is selected by Nektar, Pfizer has agreed to transfer its remaining rights and all economic benefits for Exubera and NGI. This transfer of Pfizer’s interest would include the transfer of the Exubera New Drug Application and Investigational New Drug Applications and all ex- U.S. regulatory filings and applications, continuation of ongoing Exubera clinical trials and certain supply chain transition activities.
Exubera was once predicted to produce up to $10 billion annually, with Pfizer granting 10% to 20% in sales and royalties to Nektar.
It was to be the first-ever inhaled insulin on the U.S. market and was given approval early last year (MDD, Jan. 31, 2006) but had achieved only 1% of insulin sales.
In other financings:
• Affymetrix (Santa Clara, California) said that it intends to offer, subject to market and other considerations, $250 million of unsecured senior convertible notes, due 2038, under an automatically effective shelf registration statement on file with the Securities and Exchange Commission.
The company also expects to grant the underwriter an over-allotment option to purchase up to $37.5 million aggregate principal amount of additional notes on the same terms and conditions.
Affymetrix said it intends to use the proceeds from the offering for working capital and general corporate purposes, which may include funding its operations, capital expenditures, potential acquisitions of businesses, product or technologies it believes to be of strategic importance and repurchases or redemption of all or a portion of its 0.75% senior convertible notes due 2033.
J.P. Morgan Securities is acting as the sole book-running manager of the offering. The interest rate, conversion price and other terms will be determined by negotiations between Affymetrix and the underwriter upon pricing of the notes.
• iCardiac Technologies, (Rochester, New York) said that it has completed a Series B funding round to support further research into a Personalized Cardiac Safety system, an approach developed at the company to assess cardiac risk associated with a wide range of on-market and in-development drugs.
Advantage Capital Partners, Stonehenge Growth Capital, Trillium Group, and other investors, all provided an undisclosed amount of funding for the initiative.
Since the 1990s, a wide range of drugs from anti-migraines and antihistamines to diuretics have been found to cause heart arrhythmias in certain people. In rare cases, arrhythmias can lead to sudden cardiac death. The FDA now mandates that all drugs in development go through a thorough QT study to determine if a drug prolongs the QT interval on an electrocardiogram, or ECG. QT prolongation has been associated in clinical studies with heart arrhythmias.
While iCardiac currently provides quantitative analysis to make thorough QT study results more precise, it says it also has developed a method, using its own ECG-based biomarkers, for testing an individual’s susceptibility to drug-induced arrhythmias. It said that the new funding will support further early-stage R&D of a device that enables physicians to evaluate cardiac risk for an individual patient before prescribing a drug.
• The Sagemark Companies (New York) reported that M&T Credit Services and Manufacturers Traders and Trust Company have made available up to $5.5 million in an equipment lease and line of credit finance package for the development of a radiation therapy center currently under construction in Great Neck, New York, to be owned by Premier Oncology Management (Nassau) in which Sagemark holds a 24.5% through its subsidiary Premier Oncology.
The 5,000 square foot state-of-the-art outpatient cancer treatment facility will feature a TomoTherapy Hi-Art system, one of the most advanced radiation therapy cancer treatment systems available, and is expected to open in 2008.