New products

Product and Program Updates

Even while we wait for new products to come in the hemophilia pipeline, there are improvements being made all the time with our current products. Here are two changes you might need to know about.

From Bayer: Bayer’s Factor Solutions patient support now includes a Helpline to give hemophilia A patients and caregivers a personalized point of contact for getting information on insurance, patient assistance and government assistance programs. This is for Kogenate FS users, and offers: coverage, coding, reimbursement and claim issues, verifying patient insurance benefits, understanding healthcare reform insurance changes, assessing new insurance and alternate funding sources, understanding Explanation of Benefits (EOB) statements, and determining eligibility for assistance programs.

Factor Solutions case specialists, including Spanish-speaking specialists, are specially trained and understand the unique needs of the hemophilia A community. Contact them at 1-800-288-8374 for more information.

From Pfizer: There is now a 3000 IU dose of BeneFIX available for hemophilia B patients. Pfizer Hemophilia is the first to offer this new dosage strength for hemophilia B patients. Higher doses may reduce the number of vials needed per infusion, save space at a patient’s home or on the go and, may have less waste for disposal. Learn more at www.benefix.com.

I’ll try to provide other product changes and improvements as they come in!

Great Book I Just Read
Kidnapped by Robert Louis Stevenson (Kindle version)

This is one of my favorite books from childhood. What a joy to read this historical fiction classic again, and on my Kindle! It’s 1752, Scotland, and following his father’s death, young David Balfour heads out with a letter of introduction to meet his uncle Ebenezer at the House of Shaw, which he imagines to be a great estate. Hoping for wealth and a new beginning, he instead meets a miserly old man and crumbling mansion. David soon learns that there are many secrets at Shaws, and when he tries to find out the true owner of the estate, his uncle tricks him into town, and then lures him onto a ship, where he is kidnapped to be an indentured servant in America. Rounding the north of Scotland one night, the ship crashes into another: the crew picks up a mysterious man in French dress with a thick money belt, real-life historical figure Alan Breck Stewart, a Jacobite. David overhears the captain plotting to kill Alan, and tells Alan. Together David and Alan fight off the crew of the ship, which then crashes and sinks. David survives, and wanders for days alone in the Highlands, before finding help and eventually is reunited with Alan. When they are both framed for the real-life death of Colin Roy Campbell, they flee into the Highlands and endure great suffering and starvation as they try to reach Edinburgh, for Alan wants to help David get his inheritance back, and David wants to help Alan return safely to France. The book is crackling with adventure, with great dialogue and unforgettable characters. The story will tell you about the politics and history of Scotland in the 1700s. Interesting to read, due to the Scottish dialect and strange words–making the Kindle or iPad invaluable as you can easily click on each word’s meaning. The 1960 Disney movie is faithful to the book, staring Peter Finch as Alan Breck, and wonderfully done. Five/five stars.

Wilate: a New VWD Product

This is big news for von Willebrand Disease patients: there’s a new product on the market. Wilate® just got approved by the US FDA for “treatment of spontaneous and trauma-induced bleeding episodes in patients with all types of von Willebrand disease (VWD),” according to a press release. Wilate is a high-purity plasma-derived product, which uses a double viral inactivation process in manufacturing: solvent/detergent (S/D) process and a special terminal dry-heating (TDH) system. No albumin is added as a stabilizer. Wilate is exclusively derived from large pools of human plasma collected in U.S. FDA approved plasma donation centers. Wilate will be available in the market in early 2010.

Wilate is produced by Octapharma, a Swiss-based company. This is the first time Octapharma has entered the US bleeding disorders market. Wilate will be in direct competion with Humate-P, manufactured by CLS Behring.

One thing interesting I learned is that this is the first product developed and manufactured specifically for VWD.

Here’s a quote from Octapharma: “Octapharma’s worldwide commitment to coagulation disorders dates back to Octapharma Group’s formation 25 years ago,” said Octapharma USA President Flemming Nielsen.”We are thrilled that U.S. patients will now have access to Wilate following its significant success in Europe as a next generation therapy. Octapharma is committed to providing the U.S. market with life-enhancing therapies.”

VWD patients now have more choices for treatment options. For more information, please visit www.octapharma.com.

Great Book I Just Read
Final Voyage: A Story of Arctic Disaster and One Fateful Whaling Season by Peter Nichols

Massachusetts (my home state) gave birth to the American Revolution and also the global whaling industry. This fascinating book recounts a terrible story of scores of whaling ships trapped in the Arctic region, as the captains tried to score as many whales as possible before the ice closed in for the winter. Nichols deftly parallels that story with the beginning of the whaling industry, which has direct ties to Puritans coming to the new world, religious intolerance in Massachusetts in the 1700s, and the Quakers, who almost single-handedly created this lucrative industry. Whale oil soon was lighting the homes of Massachusetts and then lubricating the machines of the Industrial Age, making some Quakers millionaires, even then. Nichols also details the decline of the industry: the discovery of crude oil in Titusville, Pennsylvania, which soon replaced whale oil; the decimation of so many whales left hunting lean. All these events culminate into a dreadful outcome for the ambitious captains of the whaling ships that last season of hunting, as they searched for the last whales in an early and fearsome storm. This book will enlighten you about many subjects, from religion and commerce, to whales and history. Three stars.

An Inspiration

Our hemophilia industry is changing as fast as you can imagine. Two weeks ago we shared that Pfizer was buying Wyeth. Now we read on the news wires that Inspiration Biopharmaceuticals, Inc. is starting phase 1 clinical trials of “IB1001,” a new recombinant factor IX product. A phase 1 clinical trial means that the product is being studied for safety, tolerability and efficacy. If this is successful, then patients will be enrolled and given the product.

The most interesting thing about Inspiration is that it is a pharmaceutical company co-founded by John Taylor, father of a child with hemophilia B. Now that’s something I think that has never happened in hemophilia before. John states, “This is the first therapy for hemophilia B patients in the past two decades. We continue to develop a factor product portfolio in both IV and non-invasive dosage forms for hemophilia and other coagulation disorders.”

Why would anyone want to develop a factor IX product in a market where recombinant BeneFIX (by Wyeth) has a 90% or more market share? Good question. Could it be lower price? What will differentiate this product from BeneFIX? Why would people switch?

I don’t know but it will be interesting to find out. Inspiration Biopharmaceuticals was founded in 2004 with the mission to revolutionize treatments for hemophilia. An exciting mission in a time of great change. Stay tuned!

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