Success Highlights:
An IPP project launched in late 1997 has fostered a string of unprecedented successes for a start-up pharmaceutical firm, including establishment of the first ever FDA approved Active Pharmaceutical Ingredient (API) manufacturing facility in Russia; market introduction of the company’s first FDA approved drug utilizing the Russian API; and creation of new jobs and profits for both U.S. and Russian partners.
Bio-Nucleonics Pharma, a privately-held company in Miami, got its start when it collaborated on a small $200,000 project with Pacific Northwest National Laboratory to design and produce sealed-source radioactive phantoms for calibration and quality-control in images produced in nuclear medicine camera scans.
Their Russian IPP project partners were the Institute of Physics & Power Engineering (IPPE) in Obninsk, the site of a 10 million watt breeder reactor and attached radiochemical production facilities, and the Research Institute of Atomic Reactors (RIAR) in Dimitrovgrad, home to the world’s most powerful nuclear reactor.
Bio-Nucleonics’ founder Dr. Stanley Satz recognized the commercial potential of former Soviet radionuclide production capacity. While working with IPPE and RIAR, he launched a number of other non-IPP projects, winning over $3 million in peer-reviewed, competitive research grants from a variety of sources to develop new radiopharmaceuticals.
“Our involvement with the IPP program resulted in a leveraging process whereby we were able to obtain other grants and make business connections that we otherwise would not have,” says Satz. “IPP has been a crucial component of our commercial success.”
While work was underway in Obninsk and with RIAR, Bio-Nucleonics concurrently initiated the complex and lengthy process of obtaining U.S. regulatory approvals for a cancer treatment drug manufactured in Russia. While this process was underway, the partners set out to make the Russian facility in Obninsk meet the stringent FDA requirements of Good Manufacturing Practice (GMP) for production. The first ever FDA inspection on Russian soil followed. Bio-nucleonics received an FDA approval letter for their first radioactive drug in 2003.
The first therapeutic radiopharmaceutical launched by Bio-Nucleonics was their Strontium Chloride (Sr-89 Injection), a drug that offers pain relief for patients with breast or prostate cancer that has metastasized or spread to bone.
While some cancer pain may be treated with surgery, external beam radiation therapy or narcotics, many patients who experience cancer bone pain at more than one site do not get adequate relief from traditional therapies. They may become resistant to pain medication or be unable to tolerate analgesics or opioids such as morphine which can cause severe nausea and vomiting.
Sr-89 acts like calcium and is absorbed in bone, accumulating in primary and metastatic sites that are growing much faster than normal bone tissue. Initially, an injection may increase pain, but within two weeks the patient begins experiencing relief. In many patients a single dose provides relief from excruciating bone pain for up to six months, a marked improvement over the few hours of relief offered by a single dose of traditional pain medication such as morphine.
The market for Sr-89 consists of 200,000 to 300,000 cancer patients a year and is growing. Bio-Nucleonics expects its market share to continue to increase. The company is already exporting its products to five countries, with EU approval expected soon.
Bio-Nucleonics isn’t counting on past successes to propel its growth. The company has an array of eight new cancer drugs and devices in the pipeline, with FDA approval for three expected by early 2007.
Thanks to a modest IPP grant nearly a decade ago, Bio-Nucleonics isthriving and the rewards of its achievements are not limited to company stakeholders. Former Soviet scientists who previously developed nuclear weapons are now using their skills to produce radiopharmaceuticals that improve the quality of life for countless cancer patients. What’s more, the non-weapons related employment that Bio-Nucleonics generates through its projects ensures that Russian scientists will not lend their talents to rogue states or terrorist groups — an arrangement that’s in the best interests of the international community.
“In many ways our company was uniquely situated to take advantage of the opportunity that IPP provided because of my background,” says Satz. “As a former practitioner of the so-called death sciences, I knew that former Soviet weapons engineers could successfully reapply their skills to advancing the life sciences, just as I had done.” Bio-Nucleonics’ success is a testament not only to the value of the IPP Program, but to the entrepreneurial spirit of Americans and Russians alike. If the collaborative atmosphere between the two nations can be sustained, the possibilities of what can be accomplished are limitless.
Bio-Nucleonics: www.bionucleonics.com