According to Teva PR, they’ve had 17,000 views in just two weeks.  But, I played the game (you know, research) and found that there was really no game to it.  You just clicked on drugs and got comparison pricing for generic substitutions over brand drugs.  I really can’t see my son spending an afternoon playing this game.  Or even 15 seconds.

You would think that with Teva’s last quarterly net sales of $4.3 billion — an increase of 20% over the comparable period in 2009 — they could afford to put together a better game.  Maybe Call of Duty: Modern Generic Drug Warfare.

You can check out the game yourself here:  Switch-n-Save — Teva’s Year Of Affordable Healthcare

*Update:  The link was not working but has now changed to a new address.

Related posts:

1. Pfizer Plans to Introduce Generic Zoloft – Will Teva have Another Bad Day?
2. Teva Launches, then De-launches, Generic Biaxin® (Clarithromycin) XL
3. FDA Wants to Put Generic Drug Approval in Faster Lane

Under the present law, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) § 505(j)(5)(B)(iv)(II)(bb) defines the term “first applicant” to mean:

As used in this subsection, the term ‘first applicant’ means an applicant that, on the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the drug.

S. 1315 would amend the definition to:

As used in this subsection, the term ‘first applicant’ means

(AA) an applicant that, on the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the drug; or

(BB) an applicant for the drug not described in item (AA) that satisfies the requirements of subclause (III).’; and

(III) An applicant described in subclause (II)(bb)(BB) shall–

(aa) submit and lawfully maintain a certification described in paragraph (2)(A)(vii)(IV) or a statement described in paragraph (2)(A)(viii) for each unexpired patent for which a first applicant described in item (AA) had submitted a certification described in paragraph (2)(A)(vii)(IV) on the first day on which a substantially complete application containing such a certification was submitted;

(bb) with regard to each such unexpired patent for which the applicant submitted a certification described in paragraph (2)(A)(vii)(IV), no action for patent infringement was brought against the applicant within the 45-day period specified in paragraph (5)(B)(iii), or if an action was brought within such time period, the applicant has obtained the decision of a court (including a district court) that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity, and including a settlement order or consent decree signed and entered by the court stating that the patent is invalid or not infringed); and

(cc) but for the effective date of approval provisions in subparagraphs (B) and (F) and sections 505A and 527, be eligible to receive immediately effective approval at a time before any other applicant has begun commercial marketing.’

In the end, this would mean that an applicant that that would have been considered a subsequent applicant subject to a first applicant’s 180-day exclusivity eligibility could now qualify as a first applicant gaining co-exclusivity of the 180-day exclusivity for all first applicants if there is no timely filed patent infringement lawsuit arising from its Paragraph IV certification, or if there is a court decision of patent invalidity or non-infringement or a substantive determination that there is no cause of action for patent infringement or invalidity.

In a related matter, the U.S. Supreme Court declined to hear the reverse payment case Arkansas Carpenters Health and Welfare Fund, Paper, A.F. of L., et al. v. Bayer AG and Bayer Corp., et al. where the Question Presented was:

Are pharmaceutical “reverse payment” agreements—whereby the manufacturer of a brand-name drug (and patent holder) pays a generic manufacturer (and alleged patent infringer) to not launch a generic version of the brand-name drug—per se lawful without regard to the amount of cash paid or the strength of the underlying patent challenge?

For now, the Supreme Court has left stand the earlier decision by the Federal Circuit upholding the district court decision granting Bayer’s motion for summary judgment, holding that any anti-competitive effects caused by the settlement agreements between Bayer and the generic defendants were within the exclusionary zone of the patent, and thus could not be redressed by federal antitrust law.

Related posts:

1. FDA Wants Your Comments on 180-Day Exclusivity Forfeiture
2. Three-Year Market Exclusivity Extension for a New Indication of a Drug
3. Bill Introduced to Limit Authorized Generics

BIO President and CEO Jim Greenwood addressed the policies expected to be considered by the Obama Administration and the 111th Congress which will impact the biotechnology industry including health care reform, stem cell research, follow-on biologics, comparative effectiveness and energy security.

Following President Obama address to Congress and the nation, Greenwood released a statement saying:

“We share President Obama’s stated goal of expanding access to health care.  We believe biotechnology can play a key role in this quest.  Biotechnology can help bring needed innovation to modernize and add efficiencies to our nation’s health care system.   Innovation in health care, including health care solutions such as new therapies and diagnostics, has always been and will continue to be central to realizing our health care goals.  Further, we believe that market-based reforms provide the best opportunity to achieve the goal of universal access while providing high quality care and incentives for the discovery and development of innovative improvements throughout the health care delivery system.”

Greenwood then discussed the importance of biotech both in the economy and in developing technologies, particularly relating to healthcare and biofuels.  A large part of the discussion focused on the expectation that there will be some kind of follow-on biologics rule proposed and the importance of data exclusivity.  Not to be confused with patents, data exclusivity is the period after the FDA approves a product during which an imitator can’t rely on the innovator’s clinical data for safety and effectiveness. It can run during and longer than the period of patent protection.

President Obama’s budget, released today, is set to remove barriers to creating generic biologics. The administration is expecting to use the money the federal government would save through use of biogenerics to help pay for a major overhaul of the healthcare system.

Unlike traditional chemical drug approval, the Food and Drug Administration currently has no process for approving biogenerics, also called “follow-on biologics” and “biosimilars.” Generally, biotech drugs are more complicated than regular drugs because they are made from living cells or bacteria.

For a generic drug manufacturer to win approval of a generic version of a traditional prescription drug, the product must have the same active ingredient, strength, dosage form and route of administration as the original drug. This means that generic drugs are the exact same chemically as their brand name counterparts and they act the same way in the body.

Such a process is not possible with biologics. Biologics manufacturers must ensure that the manufacturing process remains the same over time by controlling the source and nature of starting materials and controlling the manufacturing process. When a follow-on biologic is created, it requires a new manufacturing process with new starting materials. As a result, it will produce a product that is different from and not therapeutically equivalent with that of the brand name biologic.

The generic industry has proposed letting companies copy biologics after three to five years, similar to rules set for conventional drugs under the 1984 Hatch-Waxman Act. The administration’s proposal suggests the time frame would be consistent with Hatch-Waxman, though administration officials could not confirm that last night.

To give you an idea of the impact of these changes, last year the Congressional Budget Office estimated that the federal government would have saved $6.6 billion over 10 years under proposed legislation that would have provided biotech companies 12 years of market exclusivity for new biologic drugs.

But biotechnology companies have fought to keep a monopoly on their drugs for at least 14 years. They say they need that amount of time in order to ensure a return on the significant investment required to develop biologics. Companies also fear patents will not fully protect biologics since competitors could make a similar molecule that may not be covered by the patent.

Greenwood pointed out that in order to preserve incentives to research, develop and manufacture new innovative therapies and cures, as well as new indications for such products, any statutory pathway for follow-on biologics must include substantial non-patent data exclusivity, during which follow-on manufacturers could not rely on FDA’s prior approval of innovative biologics to support approval of their own products.

BIO supports the notion that the longer period is justifiable stating that such data exclusivity is necessary because a follow-on biologic may be similar enough to an innovative biologic for regulatory approval purposes, but different enough to avoid the innovator’s patents. Thus, non-patent exclusivity is necessary to maintain effective market protection. Further,  the industry’s heavy dependence on significant amounts of investment capital and the high risks and costs involved in the development of new biologic medicines all warrant a substantial period of exclusivity.

Greenwood stressed that any discussion must recognize that the methods used to show that one chemical drug is the same as another are different from and insufficient for biologics. Thus, versions of a biological product made by different manufacturers must be evaluated on a case-by-case basis, because they will differ from each other in certain respects.

Greenwood also pointed out that mandating a data exclusivity period below 14 years in follow-on biologics legislation would save the federal government at most an additional $1.4 billion over 10 years, a “relatively small savings” for the government’s total health budget.  On the other hand, just reducing the exclusivity period from 14 years to 10 years would reduce revenue by 12% for the biotech companies and cause a dramatic drop in R&D spending for biotechs.  BIO claims that the average biotechnology company does not cover its costs of a biologic until 17 years after the initial sales of the product.

Recent legislative proposals vary along several dimensions, including differing durations of data exclusivity. Under any new law, a follow-on biologic applicant will be required to demonstrate that there are no clinically meaningful differences in safety, purity and potency between its product and the brand product in order for the FDA to approve a follow-on biologic as interchangeable. However, the applicant must provide evidence that its product will produce the same clinical result as the brand product in any given patient and that it presents no additional safety risks or diminished efficacy if a patient alternates or is switched between products.  This will be a tough road to travel.

Biotechnology Industry Statistics

• 120 companies (30%) are now trading with less than 6 months of cash on hand. 180 companies (45%)  have less than 1 year of cash remaining.” Only 10% of the 370 public US biotech companies have positive income. (source: BIO)
• By comparison with 2007, funds raised from IPOs in 2008 fell 97% and follow-on/secondary offerings fell 56%.  Total capital raised by the industry in 2008 fell by 55% vs 2007 (source: BioCentury).
• In 2006, 32 life sciences companies raised $1.7 billion through IPOs. In 2007, 41 raised $1.9 billion. In 2008, there was only one IPO in the US, which raised $5.8 million. (source: BioWorld)  There were 19 biotech IPOs withdrawn in 2008.
• 87% of US biotech stocks have lost value in 2008 with 26% of 350 biotech companies currently trading under $1 Billion in market cap now trading below their cash value. That is, they have more cash on hand per share than the market value of their companies. This level has gone up by 3x vs 2007.(source: BIO).

The podcast is available here.

Related: Congressman Waxman Addresses GPhA Meeting on Follow-on Biologics

Related posts:

1. Will Follow-On Biologics Bill Become Law?
2. Is the FDA Set To Bring On Generic Biologics?
3. Senate Committee Approves Follow-On Biologics Bill: Fear and Trepidation Follow

Authorized generics can lead to delaying generic competition by discouraging generic companies from challenging weak and potentially unenforceable patents.  Now, Representative Jo Ann Emerson (R-MO), along with Rep. Marion Berry (D-AR), Dennis Moore (D-KS) and Zach Wamp (R-TN), have re-introducing H.R. 573, which would prohibit the marketing of an authorized generic during the 180-day generic exclusivity period following a patent challenge.

The Act would amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs. (Introduced in House).  The Act would amend Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) by adding at the end the following:

Prohibition of Authorized Generic Drugs-

(1) IN GENERAL- Notwithstanding any other provision of this Act, no holder of a new drug application approved under subsection (c) shall manufacture, market, sell, or distribute an authorized generic drug, direct or indirectly, or authorize any other person to manufacture, market, sell, or distribute an authorized generic drug.

(2) AUTHORIZED GENERIC DRUG- For purposes of this subsection, the term `authorized generic drug’–

(A) means any version of a listed drug (as such term is used in subsection (j)) that the holder of the new drug application approved under subsection (c) for that listed drug seeks to commence marketing, selling, or distributing, directly or indirectly, after receipt of a notice sent pursuant to subsection (j)(2)(B) with respect to that listed drug; and

(B) does not include any drug to be marketed, sold, or distributed–

(i) by an entity eligible for exclusivity with respect to such drug under subsection (j)(5)(B)(iv); or

(ii) after expiration or forfeiture of any exclusivity with respect to such drug under such subsection (j)(5)(B)(iv).’.

Related posts:

1. Bill Introduced to Limit Authorized Generics
2. FTC Eyes Impact of Authorized Generic Drugs
3. Do Authorized Generic Drugs Deter Paragraph IV Certifications?

According to the Commission’s complaint, filed in the United States District Court for the Central District of California, Watson and Par, through its partner Paddock Laboratories, each sought regulatory approval from the FDA to market generic versions of AndroGel. In their FDA filings, both companies certified that their products did not infringe the only patent Solvay had relating to AndroGel, and that the patent was invalid. The complaint charges that Solvay agreed to pay the generic companies to abandon their patent challenges and agree not to bring a generic AndroGel product to market for nine years, until 2015.

The court action seeks to promote competition between Solvay and generic drug makers that had sought to introduce generic versions of the branded prescription drug AndroGel. AndroGel, Solvay’s second highest selling pharmaceutical product, is a pharmaceutical gel containing synthetic testosterone. It is approved for testosterone replacement therapy in men with low testosterone levels, which often are associated with advancing age, certain cancers, and HIV/AIDS, among other conditions.

The complaint alleges that Solvay acted unlawfully to eliminate generic competition by paying Watson and Par a share of its AndroGel profits to abandon their patent challenges and agree to delay generic entry until 2015 (known as “reverse payments“). As a result, the complaint states that the defendants are cooperating on the sale of AndroGel and sharing the monopoly profits, rather than competing.

According to the Commission’s complaint, defendants’ agreements to eliminate generic AndroGel competition were, and continue to be, unfair methods of competition that violate Section 5(a) of the FTC Act. The FTC says that such payments, also called “exclusion payment settlements,” hinder the intent of the Hatch-Waxman Act of 1984.

The Commission is seeking a final court judgment declaring that Solvay’s agreements with Watson and with Par and Paddock violate Section 5(a) of the FTC Act, and injunctive relief restoring competitive conditions and barring the defendants from engaging in similar or related conduct in the future.

Today, senior Senate Judiciary Committee members Herb Kohl (D-WI) and Chuck Grassley (R-IA) unveiled The Preserve Access to Affordable Generics Act to prohibit brand-name drug manufacturers from using reverse payment agreements to keep generic equivalents off the market.

Sen. Herb Kohl (D-Wis.) had proposed a bill last year along with Sens. Dick Durbin, D.-Ill., and Charles Grassley, R.-Iowa; and now-President Barack Obama.

See the Civil Complaint [Public Version]

Related posts:

1. Paying Off Your Generic Drug Competition? No Problem.
2. Apotex To Launch Generic Plavix At Its Own Risk
3. FTC Eyes Impact of Authorized Generic Drugs