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Issue: # 80 July 15th, 2008 ~~~~~~~~~~~~~~~~~~~~~~~~~~
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Greetings! Social Quotes "You must look into other people as well as at them." -Lord Chesterfield "A good deed is never lost: he who sows courtesy reaps friendship; and he who plants kindness gathers love." -Basill "To rejoice in another`s prosperity, is to give content to your own lot: to mitigate another`s grief, is to alleviate or dispel your own." -Thomas Edwards ~~~~~~~~~~~~~~~~~~~~~~~~~~
Today`s News!!!
LEVP Lev Pharmaceuticals, Inc.
LEVP Website Finance Jul 15, 2008 -- ViroPharma Incorporated (Nasdaq:
VPHM) and Lev Pharmaceuticals, Inc. (OTCBB:
LEVP) today announced that the companies have signed a definitive merger agreement under which ViroPharma will acquire Lev, a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases, for $442.9 million of upfront consideration, or $2.75 per Lev share, comprised of $2.25 per share in cash and $0.50 per share in ViroPharma common stock (subject to a collar). Contingent consideration of up to $1.00 per share may be paid on achievement of certain regulatory and commercial milestones. The transaction with a potential net aggregate value of up to $617.5 million has been unanimously approved by the boards of directors of both companies. The companies expect the transaction to be completed by the end of 2008. In addition, concurrently with the execution of the merger agreement, ViroPharma purchased $20 million of Lev common stock.
The acquisition of Lev Pharmaceuticals further enhances ViroPharma`s pipeline with Cinryze(TM) (C1 inhibitor (human)), which is currently under regulatory review for approval by the U.S. Food and Drug Administration as a replacement therapy for patients with hereditary angioedema (HAE), also known as C1 esterase inhibitor (C1-INH) deficiency.
The use of replacement therapy in patients with C1-INH deficiency is supported by more than 35 years of clinical practice experience in Europe. C1-INH depletion is also implicated in a number of other serious inflammatory disorders.
Hereditary angioedema, or C1-INH deficiency, is a dangerous and potentially deadly inflammatory disease affecting up to 10,000 patients in the United States, caused by a genetic deficiency in an essential protein called C1 esterase inhibitor. Clinical studies have shown that prophylactic C1 inhibitor replacement therapy with Cinryze can significantly reduce the severity, duration and frequency of HAE attacks.
"This transaction is consistent with ViroPharma`s stated objective of broadening our portfolio of therapies for serious life-threatening conditions in selected specialty markets," commented Vincent Milano, ViroPharma`s president and chief executive officer. "Lev`s orphan drug Cinryze(TM) is a life-saving therapy treating a very dangerous disease. This opportunity provides a clear strategic fit with ViroPharma:
Cinryze targets a market that is addressable with modest additional infrastructure and further serves patients suffering from a disease with few treatment options.
We are very pleased to add the expertise of Lev to our organization, and Cinryze to our growing portfolio of options for underserved patient populations with critical and urgent needs." "We believe this transaction recognizes the value we have created at Lev and provides our shareholders with attractive financial terms, through the upfront payment and the opportunity to continue to share in the success of Cinryze(TM) through the ownership of ViroPharma shares and the contingent value rights," commented Judson Cooper, Lev`s chairman of the board. "Leveraging the combined resources of both companies not only strengthens our C1 inhibitor development platform, but also underscores our commitment to serving patients with critical unmet medical needs." Transaction Terms Under the terms of the merger agreement, ViroPharma will acquire the outstanding common stock of Lev for $2.25 per share in cash and $0.50 per share in stock ("Upfront Consideration"), subject to a collar. The Upfront Consideration value could be lower or higher if the ViroPharma average common share price is lower than $10.03 or higher than $15.68 per share during the twenty trading day period prior to closing. In addition, Lev shareholders will receive the non-transferrable contractual right to two contingent payments ("CVR Payments") of $0.50 each that could deliver up to an additional $174.6 million, or $1.00 per share in cash, if the Company meets certain targets. The first CVR payment of $0.50 per share would become payable when either (i) Cinryze is approved by the FDA for acute treatment of HAE and the FDA grants orphan exclusivity for Cinryze encompassing the acute treatment of HAE to the exclusion of all other human C1 inhibitor products or, (ii) orphan exclusivity for the acute treatment of HAE has not become effective for any third party`s human C1 inhibitor product for two years from the later of the date of closing and the date that orphan exclusivity for Cinryze for the prophylaxis of HAE becomes effective.
The second CVR payment of $0.50 per share would become payable when Cinryze reaches at least $600 million in cumulative net product sales within 10 years of closing.
The Upfront Consideration of $2.75 per share and the potential for a total value of $3.75 per share represent premiums of 49% and 103%, respectively, over Lev`s closing stock price on July 14, 2008.
Closing is subject to certain conditions including approval under the Hart-Scott-Rodino Act, the approval of Lev`s shareholders and other customary closing conditions.
Mr. Judson Cooper, Lev`s chairman of the board, and Dr. Joshua Schein, Lev`s chief executive officer, respectively, and their affiliates, who collectively hold an aggregate of approximately 23% of the outstanding Lev shares, have agreed to vote their shares in favor of the transaction.
Additionally, ViroPharma agreed to make a $20 million investment in Lev, at signing, by purchasing 9,661,836 shares of Lev common stock at a 10 percent premium to the five day average closing price of Lev`s shares for the period ending Friday, July 11, 2008, sold pursuant to Lev`s effective registration statement on Form S-3.
J.P. Morgan Securities Inc. advised ViroPharma and DLA Piper acted as legal counsel.
In addition, Piper Jaffray & Co. provided a fairness opinion to ViroPharma`s board of directors. J.P. Morgan Securities Inc., as successor to Bear, Stearns & Co. Inc., advised Lev and provided a fairness opinion to Lev`s board of directors.
Willkie Farr & Gallagher LLP and Becker & Poliakoff, LLP acted as legal counsel to Lev.
Conference Call and Webcast Information ViroPharma will host a live teleconference and webcast (featuring slide presentation) with senior management to discuss the strategic acquisition of Lev Pharmaceuticals on Tuesday, July 15, 2008 at 10:30 a.m. ET. Members of Lev Pharmaceuticals senior management will be available during the question and answer period. To participate in the conference call, please dial 888-299-4099 (domestic) and 302-709-8337 (international).
After placing the call, please tell the operator you wish to join the ViroPharma investor conference call.
Alternatively, the live webcast of the conference call and slide presentation can be accessed via ViroPharma`s website at http://www.viropharma.com and Lev`s website at http://www.levpharma.com. Windows Media or Real Player will be needed to access the webcast. An audio archive will be available at the same address until August 1, 2008.
Cinryze(TM) Regulatory Status On May 2, 2008, the Blood Products Advisory Committee (
BPAC) to the U.S. Food and Drug Administration (FDA) voted unanimously that there is sufficient evidence of the safety and efficacy for the approval of Cinryze for the prophylactic treatment of HAE. The data from Lev`s acute treatment trial was not presented before the
BPAC and is currently under active review at FDA. On May 6, 2008, Lev announced that FDA accepted for review Lev`s complete response submission for Cinryze targeting an action date of October 14, 2008.
About Hereditary Angioedema HAE is the result of a defect in the gene controlling the synthesis of C1 inhibitor.
C1 inhibitor maintains the natural regulation of the contact, complement, and fibrinolytic systems, that when left unrestricted, can initiate or perpetuate an attack by consuming the already low levels of endogenous C1 inhibitor in HAE patients. Patients with C1 inhibitor deficiency experience recurrent, unpredictable, debilitating, and potentially life threatening attacks of inflammation affecting the larynx, abdomen, face, extremities and urogenital tract. While there is no approved therapy for acute HAE attacks in the U.S., a commercially available C1 inhibitor has been used in Europe to treat HAE for more than 35 years. There are estimated to be 10,000 people with HAE in the U.S.
Additional information on HAE can be obtained from the U.S. Hereditary Angioedema Association at www.haea.org.
About ViroPharma Incorporated ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/Products.aspx). ViroPharma currently focuses its drug development activities in diseases including cytomegalovirus (CMV) and C. difficile.
About Lev Pharmaceuticals, Inc.
Lev is a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases. Lev`s lead product candidate, Cinryze(TM) (C1 inhibitor (human)), is being developed as a replacement therapy for hereditary angioedema (HAE), also known as C1 inhibitor deficiency. Additionally, Lev is in the process of prioritizing its C1 inhibitor development platform for the treatment of selective other diseases and disorders in which inflammation is known or believed to play an underlying role.
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Today`s News!!!
QMNM Quest Minerals & Mining Corp.
QMNM Website Finance Jul 15, 2008 -- Quest Minerals & Mining Corp. (OTCBB:
QMNM) (Frankfurt:
QMNB), a Kentucky based operator of energy and mineral related properties, is very pleased to announce that its wholly owned subsidiary, Gwenco, Inc. has hired a crew of maintenance personnel to work the second shift at its Pond Creek location.
Everett Hampton, President of Whitestar Mining, LLC. commented, "The company plans to expedite production as quickly as possible in an effort to bring its Pond Creek mine up to previously stated expectations of between 1,500 - 2,000 raw tons of coal per day and I believe that utilizing a second shift of maintenance personnel is a very positive step in the right direction. Employing this maintenance team will enable the first shift of miners to commence production operations immediately at the start of each day without being hampered with the task of performing their own maintenance and preparation, which can potentially consume hours of a typical work shift." Eugene J.Chiaramonte Jr., President of Quest Minerals and Mining Corp., stated, "I am excited to report that we have employed a shift of maintenance workers at our Pond Creek location so quickly. This move is expected to allow our first shift personnel to mine coal without focus on additional, often time consuming tasks.
Given the extremely favorable conditions currently present in the coal market, we are anxious to bring the mine into full production mode as soon as possible." About Quest Minerals & Mining Quest Minerals & Mining Corp., or Quest, acquires and operates energy and mineral related properties in the southeastern part of the United States. Quest focuses its efforts on properties that produce quality compliance blend coal.
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Today`s News!!!
HYII Hybred International, Inc.
HYII Website Finance Check This out!!! Jul 15, 2008 -- InvestSource, Inc. invites the public to hear what Gary Kouletas, the President and Founder of Hybred International (PINKSHEETS:
HYII), and Lee Vanatta, the President and CEO of PureSpectrum, Inc. (PINKSHEETS:
PSPM), have to say about their respective companies. Mr. Kouletas and Mr. Vanatta were featured in recent installments of CEOCorner, "The Fastest 60 Seconds in the Small-Cap Market." Details of the interviews can be heard at the company profiles for Hybred International and PureSpectrum on the InvestSource, Inc. (ISI) website at: www.investsourceinc.com or on the CEOCorner website at: www.ceo-corner.com.
During the course of his interview, Mr. Kouletas discussed the unique features of the Hybred composite horseshoe that provides unsurpassed shock absorption, superior traction, and improved protection for the horse, but requires no additional tools and can be fitted with traditional methods. He was especially confident that with the recent attention being paid to issues related to shoeing problems following the problems of Big Brown in the Belmont Stakes and the tragic euthanization of Eight Belles after the Kentucky Derby, now is the perfect time for Hybred to introduce its innovative design to the market. He also was optimistic that the Company`s partnership with Thoro`bred, the largest horseshoe manufacturer in the world, would provide significant distribution advantages as Hybred looks to expand and grow.
In his interview for PureSpectrum, Mr. Vanatta was keen to discuss the unique advantages of PureSpectrum`s technology that combines the efficiency of fluorescent lighting with the usability and performance of traditional incandescent bulbs. He was pleased with the results of PureSpectrum`s research and development, in which the Company`s engineers had produced the breakthroughs in power conversion technology that have generated interest from numerous companies across the globe. He also was satisfied in efforts to protect the Company`s proprietary technologies through numerous patents, and confident that these protections will help ensure PureSpectrum`s viability for many years to come.
About Hybred International:
Hybred International (PINKSHEETS:
HYII) has spent five years in research, development and testing in conjunction with advice from several of the country`s premier farriers, veterinarians and jockeys to bring to market a high quality therapeutic horseshoe which has multiple, world-wide equestrian applications. With more than a dozen ways that steel shoes are known to damage the feet, legs, and circulatory system of the horse, one of the worst damages comes from loss of shock absorption. The Hybred horseshoe is the most advanced Aluminum/Rubber horseshoe on the market today. Unsurpassed shock absorption, superior traction and improved protection, combined with the best wear resistance of any synthetic horseshoe makes the Hybred the ultimate choice for every horse.
About PureSpectrum:
PureSpectrum (PINKSHEETS:
PSPM) is a publicly traded technology company founded and headquartered in Savannah, Ga. The company`s values are grounded in an awareness of the increasing urgency to identify more efficient energy solutions. PureSpectrum currently holds the rights to multiple patents and patent applications related to an electronic ballast design which would produce a soft switching environment during power conversion for artificial lighting. PureSpectrum will continue its commitment to researching, developing and refining ideas that will provide the most energy efficient, cost effective methods for powering artificial light.
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Recent News!!!
GNTA Genta Incorporated
GNTA Website Finance July 14, 2008 -- Genta Incorporated (OTC Bulletin Board:
GNTA) announced that the Food and Drug Administration (FDA) has accepted the Company`s amendment to its New Drug Application (NDA) for Genasense(R) (oblimersen sodium) Injection as a "complete response". The NDA proposed the use of Genasense plus chemotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The recent submission was based on new information from the Company`s completed, randomized Phase 3 trial that showed, among other findings, a significant increase in overall survival for patients who achieved a complete or partial response when treated with Genasense plus chemotherapy compared with patients treated with chemotherapy alone.
The amendment responds to a communication received in March 2008 from FDA`s Center for Drug Evaluation and Research (
CDER) that denied Genta`s appeal of a prior "non-approvable" decision of the Genasense NDA in December 2006. That communication described a regulatory path forward that included but was not limited to determination of long-term survival in patients who entered the study. FDA has informed the Company that it considers Genta`s complete response as a Class 2 resubmission with a Prescription Drug User Fee Act (PDUFA) goal date of December 3, 2008.
"We are pleased that the FDA will formally review this new information, and we look forward to working with FDA`s Division of Oncology Drug Products during their consideration of this amendment," commented Dr. Loretta M. Itri, Genta`s President, Pharmaceutical Development, and Chief Medical Officer.
About Chronic Lymphocytic Leukemia CLL is the most common form of leukemia in adults. According to the American Cancer Society, approximately 8,000 patients will be diagnosed this year. More than 60,000 people in the U.S. currently have CLL. The disease arises in lymphocytes, a type of white blood cell that normally produces antibodies and serves important immune functions. Patients with CLL typically develop symptoms that may progress over a period of years, ultimately producing a generalized depression of immunity, marked increases in the size of spleen, liver and lymph nodes, and impaired production of other normal blood cells. Eventually, these problems may cause life-threatening complications, such as overwhelming infections and fatal bleeding. More information about CLL can be accessed at the website for the Lymphoma Research Foundation at:
http://www.lymphoma.org.
About Genasense Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.
About Genta Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company`s research platform: DNA/RNA-based Medicines and Small Molecules. Genasense(R) (oblimersen sodium) Injection is the Company`s lead compound from its DNA/RNA Medicines program. Genta is currently recruiting patients to the AGENDA Trial, a global Phase 3 trial of Genasense in patients with advanced melanoma.
The leading drug in Genta`s Small Molecule program is Ganite(R) (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer-related hypercalcemia that is resistant to hydration.
The Company has developed G4544, an oral formulation of the active ingredient in Ganite, that has recently entered clinical trials as a potential treatment for diseases associated with accelerated bone loss. The Company is also developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drug as paclitaxel and docetaxel. Ganite and Genasense are available on a "named-patient" basis in countries outside the United States.
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SUPI Superwire, Inc.
SUPI Website Finance Superwire.com, Inc. provides communications and information technology (IT) solutions to small-to-medium enterprises (SMEs). The company`s services include Internet access, Internet security, virtual private networks (VPN), local and long distance telephone service, network monitoring and management, personal computer (PC) support and maintenance, disaster recovery, and technology consulting. It is based in Newport Beach, California.
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Recent News!!!
NPIA NPI08, Inc.
Finance Jul 14, 2008 -- Infinity Capital Group, Inc. today announced that it has closed the acquisition of approximately 87.5 percent of the issued and outstanding shares in NPI08, Inc. (PINKSHEETS:
NPIA) ("the Shares") after the Denver Federal Bankruptcy Court approved the sale. The consideration for the transaction included a combination of cash, Infinity common stock, and a promissory note to the Sellers collateralized with the Shares pending payment.
Infinity intends to utilize its controlling ownership to facilitate a reverse merger between
NPIA and a privately held, growth-oriented operating business that is seeking to access capital and a public market. Upon consummating the
NPIA share purchase, Infinity CEO Greg Laborde stated, "In today`s capital markets, where access to public capital and liquidity options for small companies are limited, we are pleased to have taken control of another vehicle which will enable us to help a thriving privately held company to grow and expand while providing their current owners potential liquidity." Mr. Laborde continued, "We see access to public capital as a vital service to growing companies who are the engine for overall economic growth and see tremendous opportunity for Infinity to earn attractive investment returns while facilitating this important capital formation need." Infinity intends to make a follow on investment in
NPIA in connection with the reverse merger and as part of its mission as a business development company it will provide management assistance in connection with and post closing the merger. The
NPIA plan is similar to Infinity`s January 2008 transaction where it facilitated a reverse merger between a controlled publicly traded subsidiary and two related privately held growth companies,
REGS, LLC and Tactical Cleaning, LLC -- creating the Infinity portfolio company Strategic Environmental & Energy Resources, Inc. (PINKSHEETS:
SENR). In connection with the
SENR transaction, Infinity invested its own capital and assisted the company in attracting additional investment from other sources.
Infinity targets privately held emerging growth companies, across a broad range of attractive industries, with revenues of US$5-$15 Million, whose growth is constrained by limited capital. Infinity seeks companies with strong management teams that are at or near profitability and have the potential to list on a National Exchange within 12-18 months. In a typical transaction, Infinity will provide long term capital, primarily via equity investments, and as a business development company Infinity provides managerial assistance throughout the process and post closing of the transaction.
Its mission is to offer entrepreneurial businesses a viable financing alternative to traditional private equity and venture capital funds that generally insist on control while also providing the incumbent business owners with personal liquidity and a potential exit strategy.
In addition to target merger candidates, Infinity is seeking controlling interest in public companies looking to change strategy, that have sold or closed a business and whose shareholders will participate in a subsequent transaction.
About Infinity Capital Group, Inc.
Infinity Capital Group is a business development company that provides early-stage or mezzanine financing and management assistance to emerging growth companies. The company typically invests in companies that intend to go public through an IPO or by a reverse merger with an already public firm. It also funds small public companies that are undergoing significant change in strategy. Investments by Infinity are not limited to any particular industry.
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LEVP QMNM HYII GNTA SUPI NPIA ~~~~~~~~~~~~~~~~~~~~~~~~~~
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