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[genet-news] PHARMACROPS: U.S. drug firm drops GE safflower insulin option offered by SemBioSys



                                  PART 1


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TITLE:  U.S. DRUG FIRM DROPS SAFFLOWER INSULIN OPTION

SOURCE: Country Guide, Canada

AUTHOR: 

URL:    http://www.country-guide.ca/west/issues/ISArticle.asp?id=98280&issue=04022009&story_id=&PC=FBC

DATE:   04.04.2009

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U.S. DRUG FIRM DROPS SAFFLOWER INSULIN OPTION

A Los Angeles-area drug company that paid for a year-long option to license the rights to a Calgary firm?s plant-produced insulin has let the option lapse.

MannKind Corp.?s option on SemBioSys Genetics? insulin product, produced in genetically modified safflower plants, expired on Tuesday ?without action,? SemBioSys said in a release Wednesday.

MannKind?s decision follows its announcement March 9 that it would buy drug giant Pfizer?s insulin facility at Frankfurt, Germany for US$33 million, including a license to make bulk insulin there for its rapid-acting pulmonary insulin product, Afresa.

Afresa, now in clinical studies, is meant to be an inhalable form of insulin delivered through a small palm-sized device. MannKind?s option, if exercised, would have made Afresa the ?primary use? of SemBioSys? safflower-based product.

The decision by MannKind, which paid US$2.5 million for its option with SemBioSys, now leaves the Calgary company ?free to execute agreements relating to its insulin program with other parties,? SemBioSys said Wednesday.

?Bioequivalent?

But the news also comes just as SemBioSys reported results from the Phase I/II trials of its safflower-based recombinant human insulin in human volunteers. In the tests, SemBioSys? SBS-1000 product was ?shown to be bioequivalent to Eli Lilly?s Humulin,? a widely-used human insulin.

?While the MannKind option was attractive from a timing point of view, and provided a valuable cash infusion, additional partnering options may be open to us now that we have positive clinical data for plant-made insulin,? SemBioSys CEO James Szarko said Wednesday.

?Based on prior discussions with third parties, we believe that our recent clinical trial results position us well to continue and expand our partnership discussions.?



                                  PART 2

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TITLE:  SEMBIOSYS PROVIDES UPDATE ON INSULIN PROGRAM

SOURCE: SemBioSys, Canada

AUTHOR: Press Release

URL:    http://micro.newswire.ca/release.cgi?rkey=1704016279&view=36078-0&Start=0

DATE:   01.04.2009

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SEMBIOSYS PROVIDES UPDATE ON INSULIN PROGRAM

CALGARY, April 1 /CNW/ - SemBioSys Genetics Inc., specializing in the manufacture of high-value proteins and oils in plant seeds, provides an update on its proprietary plant-produced recombinant human insulin program. In December 2008, SemBioSys announced that MannKind Corporation purchased a non-refundable option to license rights to SemBioSys? proprietary plant-produced recombinant human insulin to be used primarily for AFRESA(TM), MannKind?s ultra-rapid acting insulin product. At the time the option was taken, MannKind had completed diligence related to the SemBioSys insulin program and final written agreements had been prepared for execution, were the option to be exercised. In March 2009, MannKind announced that it had entered into agreements with Pfizer Inc. ?to purchase Pfizer?s insulin facility at Industriepark Hoechst, Frankfurt am Main, Germany and assets related to the production of bulk insulin, including the relevant real property rights, the production equipment
 , a quantity of bulk insulin and a license to manufacture bulk insulin for use in pulmonary delivery.? The option period for SemBioSys? agreement with MannKind expired yesterday without action and SemBioSys is now free to execute agreements relating to its insulin program with other parties. Also in March 2009, SemBioSys reported results from the Phase I/II trial of its recombinant human insulin (SBS-1000) in human volunteers. SBS-1000 was shown to be bioequivalent to Eli Lilly?s Humulin(R) R, a widely-used human insulin in North America.

?Based on prior discussions with third parties, we believe that our recent clinical trial results position us well to continue and expand our partnership discussions,? said James Szarko, Chief Executive Officer of SemBioSys. ?While the MannKind option was attractive from a timing point of view, and provided a valuable cash infusion, additional partnering options may be open to us now that we have positive clinical data for plant-made insulin.? About SemBioSys

Calgary, Alberta-based SemBioSys is a world leader in manufacturing high-value proteins and oils in plant seeds. With its unique, proprietary platform, SemBioSys provides partners with product enablement, exceptionally low cost and unprecedented scalability. The Company applies this platform with high selectivity to opportunities where it has a unique competitive advantage. Since its inception, SemBioSys has produced more than 50 non-native proteins and oils using its patented seed technology, demonstrating applicability across a broad range of industries such as pharmaceuticals, personal care and industrial products. The Company?s current pharmaceutical development programs include insulin (SBS-1000, regulated as a biosimilar in Europe) and Apo AIMilano, a next-generation cardiovascular therapy. SemBioSys is listed on the Toronto Stock Exchange under the ticker SBS. More information is available at www.sembiosys.com.



                                  PART 3

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TITLE:  MANNKIND AGREES WITH PFIZER ON THE PURCHASE OF FRANKFURT INSULIN MANUFACTURING PLANT

SOURCE: MannKind, USA

AUTHOR: Press Release

URL:    http://www.news.mannkindcorp.com/phoenix.zhtml?c=147953&p=irol-newsArticle&ID=1263905&highlight=

DATE:   09.03.2009

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MANNKIND AGREES WITH PFIZER ON THE PURCHASE OF FRANKFURT INSULIN MANUFACTURING PLANT

VALENCIA, Calif., March 9 /PRNewswire-FirstCall/ -- MannKind Corporation today announced that it has entered into agreements with Pfizer Inc. to purchase Pfizer?s insulin facility at Industriepark Hoechst, Frankfurt am Main, Germany and assets related to the production of bulk insulin, including the relevant real property rights, the production equipment, a quantity of bulk insulin and a license to manufacture bulk insulin for use in pulmonary delivery. The aggregate purchase price is $33 million, subject to certain adjustments. At MannKind?s option, up to $30 million worth of the company?s common stock may be issued to Pfizer at closing and applied toward the full purchase price. The transfer of certain real property rights pursuant to this transaction will require the consent of third parties.

Upon the closing of this transaction, MannKind intends to retain more than half of the current workforce, subject to consultation with the works council and employee co-determination rights, and plans to operate the facility at a production level commensurate with the company?s present needs for recombinant human insulin.

In the event some or all of the third-party consents are not obtained, only the bulk insulin, the license to manufacture bulk insulin for use in pulmonary delivery and, potentially, certain removable equipment will be transferred to MannKind at closing.

?The insulin plant in Frankfurt is a state-of-the-art insulin production facility that would make an excellent counterpart to our formulation, fill and finish facility for AFRESA in Danbury, Connecticut,? said Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. ?Upon the closing of this transaction, we will obtain an immediate supply of insulin and the ability to supply our insulin needs for the future, even if we are unable to acquire the facility itself. We are pleased with this opportunity to secure our insulin supply, which brings AFRESA one step closer to commercial readiness.?

Additional information about this transaction is available in a Current Report on Form 8-K filed by MannKind with the Securities and Exchange Commission earlier today.

About AFRESA(R)

AFRESA is an ultra rapid acting insulin product that has completed Phase 3 trials. The pharmacokinetic profile of AFRESA sets it apart from all other insulin products. The large surface area of the lung provides unique access to the circulatory system. The pH-sensitive AFRESA particles immediately dissolve upon contact with the lung surface, releasing insulin monomers that rapidly enter the bloodstream. It achieves peak insulin levels within 12-14 minutes of administration, effectively mimicking the release of meal-time insulin observed in healthy individuals, but which is absent from patients with diabetes.

About MannKind Corporation

MannKind Corporation focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer. Its pipeline includes AFRESA, which has completed Phase 3 clinical trials, and MKC253, which is currently in phase 1 clinical trials. Both of these investigational products are being evaluated for their safety and efficacy in the treatment of diabetes. MannKind maintains a website at http://www.mannkindcorp.com to which MannKind regularly posts copies of its press release as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to email alerts that are sent automatically when MannKind issues press releases, files its reports with the SEC or posts certain other information to the website.



                                  PART 4

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TITLE:  SEMBIOSYS GENETICS INC. ANNOUNCES CLINICAL RESULTS WITH PLANT-PRODUCED INSULIN

SOURCE: SemBioSys, Canada

AUTHOR: Press Release

URL:    http://micro.newswire.ca/release.cgi?rkey=1703192326&view=36078-0&Start=0

DATE:   19.03.2009

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SEMBIOSYS GENETICS INC. ANNOUNCES CLINICAL RESULTS WITH PLANT-PRODUCED INSULIN

SBS-1000 shown to be bioequivalent to Humulin(R) R (recombinant human insulin)

CALGARY, March 19 /CNW/ - SemBioSys Genetics Inc., specializing in the manufacture of high-value proteins and oils in plant seeds, today announced preliminary results of its first ?in-man? clinical study of SBS-1000, a recombinant human insulin manufactured using its proprietary platform. The trial demonstrated that SBS-1000 was bioequivalent to a recombinant human insulin with the expected safety profile.

Highlights from the preliminary analysis were:

- SBS-1000 was bioequivalent to Eli Lilly?s Humulin(R) R, a widely-used human insulin in North America, meeting all four of the endpoints outlined below.

- SBS-1000 in humans showed pharmacokinetics and pharmacodynamics indistinguishable from Eli Lilly?s Humulin(R) R, as SemBioSys had previously shown in animals.

- SBS-1000 was well tolerated at pharmacologically active dosages.

In this single administration, double blind trial, 23 healthy volunteers were administered the same dose of SBS-1000, Humulin(R) R (recombinant human insulin marketed in the US by Eli Lilly) and Humulin(R) S (recombinant human insulin marketed in the UK by Eli Lilly) in a three way cross-over study. This euglycemic clamp study coupled insulin administration with glucose infusion to maintain the volunteers? blood sugars at baseline levels.

Preliminary data are available for the primary endpoints of 1) total insulin exposure, calculated from the measured blood levels for insulin for eight hours post-injection (AUC(insulin0to8hrs)); 2) maximum concentration of insulin (Cmax(insulin)); 3) total glucose infused over eight hours (AUC(GIR0to8hrs)); and 4) maximum glucose infusion rate (GIR(max)).

Bioequivalence is declared when the comparisons between two products indicate that statistically there is confidence that the two products fall within a range of 80-125% of one another for each variable.

In this study, both SBS-1000 and Humulin(R) R were bioequivalent to Humulin(R) S with respect to total insulin exposure, maximum concentration of insulin and total glucose infused. The only anomalous result from this trial relates to some of the Humulin(R) S data. Neither SBS-1000 nor Humulin(R) R was bioequivalent to Humulin(R) S with respect to the maximum glucose infusion rate. This difference between the two reference standards (Humulin(R) R and Humulin(R) S) was not expected in such a trial and relates, at least in part, to random outliers that occurred in the Humulin(R) S arm and higher overall variability for this endpoint in the trial.

While final analyses regarding safety data are not yet available, the adverse events observed were typical for a study involving recombinant human insulins. The most common events were insulin injection site reactions, pain at the site of glucose infusion, headache and dizziness, with all similar rates of occurrence for both Humulins and SBS-1000. There were no serious adverse events and there were no events indicative of a systemic allergic response to any of the insulins.

?This is the first time one of our plant-derived recombinant proteins has been studied in humans and we were gratified to see that SBS-1000 performed in an equivalent manner to marketed recombinant human insulin with respect to pharmacologic activity and tolerability,? said Dr. Maurice Moloney, Chief Scientific Officer and founder of SemBioSys. ?We would anticipate that full results of this trial will be submitted to a future scientific conference once all data have been analyzed.?

?These results represent a significant milestone for SemBioSys. We have now demonstrated that we can consistently obtain regulatory approval to grow our insulin safflower crops. We have shown that we can extract, purify and formulate insulin from plant seeds to USP and EP standards and finally, we have obtained regulatory approval in the US and Europe to administer SBS 1000 in a phase I/II clinical trial, where our insulin was been found to be biologically active without any unexpected adverse reactions,? commented James Szarko, Chief Executive Officer at SemBioSys. ?We are continuing optimization work targeted at streamlining the production process to further improve cost of goods.?

About SemBioSys

Calgary, Alberta-based SemBioSys is a world leader in manufacturing high-value proteins and oils in plant seeds. With its unique, proprietary platform, SemBioSys provides partners with product enablement, exceptionally low cost and unprecedented scalability. The Company applies this platform with high selectivity to opportunities where it has a unique competitive advantage. Since its inception, SemBioSys has produced more than 50 non-native proteins and oils using its patented seed technology, demonstrating applicability across a broad range of industries such as pharmaceuticals, personal care and industrial products. The Company?s current pharmaceutical development programs include insulin (SBS-1000, regulated as a biosimilar in Europe) and Apo AI(Milano), a next-generation cardiovascular therapy. SemBioSys is listed on the Toronto Stock Exchange under the ticker SBS. More information is available at www.sembiosys.com.


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