The Big Red Biotech Blog

Random Coffee Cake Recipe

I found this in Parade magazine and made it for my kids and me when they were visiting over Christmas break. It was delicious and we decided it was definitely "a keeper".

Cranberry Upside-Down Cake

• 1 1/2 cups fresh cranberries (I used canned whole because I had them)
• 2 Tbsp chopped walnuts
• 1 tsp grated orange rind
• 1/2 cup butter, softened and divided
• 1/2 cup packed brown sugar
• 2 Tbsp freshly squeezed orange juice (I used a blood orange that I had)
• 1/4 tsp cinnamon
• 1 1/2 cups all-purpose flour
• 1/2 tsp salt
• 1 tsp baking powder
• 1 cup granulated sugar
• 1 tsp vanilla extract (used some from Madagasscar that was on hand)
• 1 egg
• 1/2 cup fat-free buttermilk (I used regular 2% milk)

For the glaze

• 1 cup confectioner's sugar
• 1 tsp melted butter
• 2 Tbsp freshly squeezed orange juice

How do we make this classic? 

1. Preheat oven to 350 F. Coat a 9-inch square or a 9- or 10-inch round baking pan with cooking spray and dust with flour
2. Combine cranberries, walnuts and orange rind in a  small bowl.  In a saucepan, melt 2 Tbsp butter over medium.  Stir in brown sugar, orange juice and cinnamon. Cook for 3 minutes, stirring constantly. Pour into your pan. Sprinkle cranberry mixture on top.
3. Whisk flour, salt and baking powder in a medium bowl.
4. In a large mixing bowl, with an electric mixer (I did by hand and it worked fine) set on medium, beat granulated sugar and remaining butter until creamy.  Add vanilla, egg, buttermilk to the flour mixture. Spoon over the cranberries.
5. Bake 40 minutes or until a toothpick inserted in center of the cake comes out clean.  Cool in pan for 5 minutes.  Invert onto a (plate) on rack to finish cooling. Beat glaze ingredients. Drizzle over cake and serve.

It was very rich and sweet.  But very good. Cranberries help temper sweetness of other ingredients. Serves 4-5.

Posted by Bruce Lehr Jan 19th 2013.

States Are Crafting Biosimilar Laws

This is an intersting post from Pharmalot.  As we know, FDA has not approved any biosimilars yet and have not determined whether a biosimilar could be interchanged or substituted for the original biological.

Never Mind FDA, States Are Crafting Biosimilar Laws // Pharmalot.

Don't let that be a deterrent.  Six States so far -- including Illinois, Pennsylvania and Virginia -- are already crafting bills that would allow substitution or interchangeability (if FDA says OK).  Can't be left waiting in the gate can we?  This is what makes America great!

Posted by Bruce Lehr Jan 18th 2013.

WIPO Report says China Takes Lead in New Patent Apps

The Patent Doc blog summarized a new report from the World Intellectual Property Organization (WIPO) that shows world patent filings grew by 7.8% in 2011, and China reached the top as judged by number of patent applications filed.  Yes.  China's State Intellectual Property Office (SIPO) became the world's largest by new applications with 526,412, followed by USPTO with 503,582 and JPO (Japan) with 342,610. 

In the past 100 years, only 3 patent offices have ever led in the number of new applications -- those being US, Japan and Germany's Deutsches Patent and Marktnamt (DPMA).  In 2011, 2.14 M applications were filed worldwide and this is the first time the 2 million mark has been breached.

Finally, with respect to country of origin, residents of Japan filed the largest number of applications worldwide (472,417), followed by Chinese residents and then US residents. Digital communications apps grew fastast at 8.1%, and biotech apps grew by 3%, while pharma actually dropped by 1.6%.  So much for pharma R&D productivity! Japan also had the highest number of granted patents with 238,323 and was followed closely by the US with 224,505. Look for the Chinese to catch up here too in the near future.

Posted by Bruce Lehr Jan 17th 2013.

Breakthrough Therapy Designation

In the fifth renewal of PDUFA, section 902 authorized a 'Breakthrough Therapy Designation' to speed regulatory review and (potential) approval of drugs that offer "substantial improvement over existing therapies on 1 or more clinically significant endpoints such as substantial treatment effects observed early in clinical development". 

When a application is submitted, the agency has 60 days to grant 'breakthrough' status or not. If 'breakthrough status' is designated, then the applicant can collaborate closely with the FDA on trial design for the intended patient populations reflecting the most up to date thinking on design.  A quick approval provides potential huge benefits to not only target patient populations but to the company sponsor itself - it could have a tremendous impact on economic state of smaller companies. This could give shot to investors as well with a more predictable pathway and shorter timelines to commercialization.

Thus the door is opened to the FDA for another accelerated approval pathway. The agency is encouraging applications. Said Janet Woodcock, "...We're excited about it.  In fact, although the law is only a few months old, we're already putting it to use. Recently, we identified the first therapy (Vertex's Kalydeco for some CF patients) to this special designation. And it likely won't be long before we have more..."  See Xconomy.

Posted by Bruce Lehr Jan 15th 2013.

Solstice Delivers the RNAi

Solstice Biologics says that is has solved the problem of delivering RNAi into a cell with its new 'limitless' RNAi technology.  The technology employs a covalently bound molecule to form an RNAi pro-drug -- called Ribonucleic Neutrals (RNN).  The pro-drug crosses the membrane and is converted by an intracellular enzyme into an active RNAi drug. 

Company founder, Steven Dowdy, says "The only reason that these Big Pharmas got out of the RNAi business was because of delivery.  Therefore by solving the delivery problem it will likely bring most of them back inside to take a second look."

Previously, Novartis, Roche and others have withdrawn from clinical programs in the RNAi area. Seemingly Solstice believes, 'if you build it they will come'. We'll see. See In-Pharmatechnologist.

Posted by Bruce Lehr Jan 15th 2013.

Analysts Pick their Top Phase III Drugs in 2013

The analysts have lined up their projections for most likely drugs to hit it big, e.g. achieve blockbuster status, in 2013.  Without further adieu, their picks:

• BiogenIdec, BG-12, multiple sclerosis
• J&J, canagliflozin (SGLT2 drug), diabetes
• Novo Nordisk, Tresiba (long-acting insulin), diabetes
• Novo Nordisk, liraglutide, obesity
• Gilead & AbbVie, hepatitis C
• Roche, T-DM1, breast cancer
• Roche, bitopertin, schizophrenia
• GSK, darapladib, heart disease
• GSK, MAGE-A3, cancer vaccine

There you have it. Place your bets for 2013.  You won't have that long to wait to see how it shakes out. See Fierce Biotech.

Posted by Bruce Lehr Jan 15th 2013.

India's Government Targets Cancer Drugs

India's government has been rattling sabres for some time with regard to high priced drugs and compulsory licenses.  Now they will go after three more cancer drugs and their makers to force licenses.  The drugs are Roche's Herceptin (breast cancer), BMS' Ixabepilone chemotherapeutic agent, and Dasatinib for leukemia. 

Last year, the government forced Bayer to give a compulsory license for its Nexaver (kidney and liver disease).  The drug's price dropped by a whopping 95% in country after the generic maker Natco Pharma took a license.

This is all about the price Western companies charge in India for cancer meds.  Herceptin is priced at $1400 per month, Ixabepilone is similarly priced and Dasatinib is priced at $300 per month.  These are out of the reach of India's common man.

One enthusiastic oncologist was quoted , "It's a very good move and will not just benefit Indians but possibly also bring down cancer drug prices in countries where the pharma market is not controlled by the US and western European countries."

Said another patient advocate from the group Knowledge Ecology International, "Companies like Roche have cut prices of Herceptin in the past but the price cust has been a joke."

So there continues to be a strong backlash against western style pricing in emerging markets like India. This will no doubt result in companies having to re-evalute their competitive strategies in these markets -- and certainly will affect the profits they can expect.  The so-called pharmerging markets are fighting back more frequently now and may not be the panacea once supposed for Big Pharma struggling to gain new profits to make up for those that have gone over the "patent cliff".  India, for sure, is not cooperating so far. See Pharmalot.

Posted by Bruce Lehr Jan 15th 2013.